20. The provisional views set out below provide our current thinking on this case. These views are subject to change dependent on any comments we receive about their contents. We are open to considering any new information shared with us before we reach a final decision.
The Trust failed to correctly obtain informed consent to place her daughter in a coma as it did not explain the risk of death that intubation could carry or suggest alternative treatment options
21. Mrs X’s concern on this issue centres on whether her daughter was fully aware of the risks associated with intubation and whether this course of action resulted in lost opportunities for a different outcome for her.
22. We asked our adviser if the decision to intubate was clinically appropriate. They said it was, as Miss Y was at risk of imminent death if this was not done at the time it was. She had deteriorated over the night of 27-28 December and her blood oxygen saturation levels were poor and dropping (her inspired oxygen requirement had increased from 60 to 95%) and she required additional respiratory support in the form of a Continuous Positive Airway Pressure (CPAP) mask to help deliver the oxygen and help her breathe. She was now on 100% oxygen therapy and yet her oxygen saturations still kept falling.
23. Miss Y was needing more clinical treatment and despite that, her medical notes (nursing, medical and physiotherapy) show ample evidence of respiratory fatigue e.g. use of accessory muscles. The available evidence shows this was not due to an inability to breath (i.e. lack of respiratory drive), but her lungs failing to effectively transfer oxygen into the bloodstream. She had initially compensated for this with increased respiratory efforts. Her supporting respiratory muscles were now tiring out, and she was exhausted from days of this continued effort. This was not sustainable.
24. It was therefore no longer possible for her to maintain sufficient respiration without mechanical assistance. Her oxygen saturations continued to drop despite maximal treatment and oxygen therapy support, and she was quickly approaching the point of respiratory failure. Our adviser confirmed that, if there had been no intervention, the trend would have continued, and she would have died within hours from respiratory failure regardless of the cause of the poor oxygen transfer.
25. Given this set of circumstances, the choice at that point was to mechanically ventilate or accept inevitable death within a short time. Our adviser notes Miss Y (and her parents) had made it clear before she became too ill to talk, that maximum efforts should be made to prolong her life. We note that by the time the medical team were needing to consider ventilator use, Miss Y was unable to hold detailed discussions as she was on full oxygen and using a CPAP mask, but she still had capacity to make her own decisions and confirmed her agreement to go ahead with the procedure.
26. Based on this our adviser said it was a reasonable decision to intubate her to place her on a ventilator. It would allow more time to investigate the cause of the problem and establish if it was possible to resolve it. This was in the patient’s best interests and aligned with her stated wishes.
27. It remains that Miss Y did consent and her capacity to make those decisions is not contested. We respect Mrs X’s view that her daughter may not have consented if the risk of death from intubation had been explained, and that this renders her decision not fully informed and invalid. As it would not be possible to prove what Miss Y thought at the time we must come to a view based on the available circumstantial evidence.
28. We think that, on balance of probability, Miss Y would have known there was a risk she may die from intubation. She had already survived life threatening illness previously and, we think, would have been acutely aware that she was in a life-threatening condition currently. A patient who is unaware of the risk of death would not explicitly tell their treating doctors they wanted them to make every effort to help them survive.
29. After those initial discussions Miss Y would have been fully aware that her condition was getting steadily worse, and she was now tiring from the physical efforts needed to compensate for her respiratory failure. The implications of this would have been clear. We saw no evidence of any event which may have changed her mind on this in the interim between her sharing her intentions upon admission to hospital and being asked to consent to intubation four days later.
30. On the matter of explicitly stating there may be a risk of death to Miss Y from intubation, we note the Trust responses explain that this was not stated in the discussions with her immediately prior to intubation. The Trust said the medical team felt it would be unnecessarily distressing to point this out. We do not think a patient who is being asked to consent to being placed into an induced coma so they can be maintained on life-support would be unaware that there is a risk they could die in the process.
31. What we do know is that the medical team explained its reasoning for planning to intubate her, and her consent obtained before it was done. Essentially, we think Miss Y would have understood that, if she was not placed on a ventilator to take over the efforts of aerating her lungs (the only remaining option available), she would die within hours.
32. Therefore, we cannot agree that Miss Y’s consent was invalid. There is enough evidence available to indicate she was able to receive information, understand it, and make decisions, even if her physical state prevented her engaging beyond confirming she wanted to go ahead.
33. General Medical Council: ‘Decision making and consent’ sets out the guidance which is relevant in Miss Y’s case. Section 62-64 ‘Treatment in emergencies’ sets out how decisions can be made in the best interests of a patient in an emergency if they are otherwise unable to engage in consenting discussions. Section 87-96 ‘Circumstances that affect the decision-making process’ deals with situations where decisions have to be made for those who lack capacity.
34. Our adviser confirmed the decision to proceed with intubation with the level of consent available at that point was fully in line with the established guidance. They note that Miss Y did not lack the capacity to make and understand decisions at that point as she was still conscious. However, she did lack the capacity to engage with any meaningful decision making beyond confirming or declining. She was no longer able to communicate, her physical state would only worsen, and there was no time left to delay making a decision if her immediate death was to be avoided.
35. Mrs X says her daughter was not informed of the risk of death for intubating. It should be noted that intubating a patient does carry risks, and it is possible a patient could die during the procedure. However, the records confirm that the intubation procedure was entirely successful and there were no complications. Miss Y did not die from a failed intubation.
36. Mrs X says she was misled by the medical team who, said dying would be an unlikely outcome. If such a discussion happened, this would have been an accurate statement to make. Miss Y did not die due to any issue with placing her in a coma. This was done in the course of her care by necessity, and her death occurred several weeks later. We are seeing no link between these events.
37. Our adviser explained that, for Miss Y, there was only a binary option available on 28 December 2023. The medical team had a stark choice of either attempting intubation and giving her a chance of avoiding her life ending within hours, or not attempting intubation, which would render her death unavoidable within hours. There were no other alternative choices.
38. Mrs X cites how her daughter may have chosen not to be intubated to spend time with her family or persevere with antibiotics. Unfortunately, neither of these were viable. On balance of probability, we think Miss Y knew this. It is apparent to us from the rate of deterioration that Miss Y would have continued to lose consciousness and then die within, at most, a few hours if not for the actions taken. This means there would be no opportunity for meaningful family time, waiting to see if there was an improvement in her condition, or trying other things.
39. Our adviser noted that antibiotics can help clear a bacterial infection but would have no effect on the cause of Miss Y’s underlying problem. She did have a viral infection initially, which antibiotics would also have no effect on, but the antiviral medication she had been placed on upon admission appears to have cleared that infection quickly.
40. We note both medications were continued indefinitely as a precaution due to her compromised immune system. She survived for nearly another month with no evidence of any viral or bacterial infection. There is no evidence to support the cause of her progressive respiratory failure being due to anything other than bronchiolitis obliterans.
41. As consent for placing Miss Y on a ventilator appears to have been done entirely in line with established guidance, the rationale for making this decision was sound, and there is no evidence of any harm to her from being placed in a coma in order to sustain her life, we do not uphold this part of the complaint.
42. A decision not to proceed would, in every practical sense, be inconsistent with her stated wishes that every effort be made to help her survive her illness. Correct informed consent does appear to have been obtained, and as there was no other option left, there were no alternative treatments to suggest.
43. We acknowledge Mrs X’s strength of feeling on this issue and her hope to find some way that her daughter’s sad outcome could have been different. We hope the above helps clarify the situation. Sadly, the evidence strongly indicates there was nothing more that could have been done for her daughter in the situation.
The Trust failed to provide appropriate care for her daughter’s acute illness
44. Mrs X complains that the Trust did not do enough to save her daughter’s life, and the care provided was not appropriate. After careful consideration of this we did not find evidence to support that view. She highlighted a number of specific points we have looked at to help us decide if this was the case, which we have considered as follows:
Insufficient clinical history 45. Mrs X says the Trust failed to obtain relevant clinical history from another NHS providers to inform her treatment, until it was too late to act. Our adviser was unable to find anything in the medical records to indicate an appropriate level of information was not sought, and obtained, by the Trust.
46. There is evidence of the Trust liaising with colleagues from Queen Elizabeth Hospital Birmingham (QEHB) and including their input in its considerations. The Trust also sought a second opinion from experts at Glenfield Hospital, Leicester and Royal Brompton Hospital. They said they found nothing to indicate the Trust was not open to new information sources or that it received any new information later which would have altered the outcome for Miss Y.
47. Sadly, there is currently no way to repair the damage to lungs caused by bronchiolitis obliterans. Once the tissues that transfer oxygen to the bloodstream are affected by this condition the loss of function is permanent.
48. We can understand why Mrs X felt the Trust delayed seeking input as sought on 8 January, two weeks after intubation. We note that the Trust referenced Miss Y’s relevant clinical history in its enquiry email to QEHB. The email references this from QEHB clinical letters as far back as 2021, so we see the Trust was already aware of Miss Y’s clinical history regarding bronchiolitis obliterans from the medical records available to it from her admission. We see the email is not a request for relevant clinical history, which was already known. It is a summary of the situation and request for QEHB’s view on what could be done to further support Miss Y’s suppressed immune system in addition to what had already been done.
49. In relation to the concern of not acting until it being too late to act, our adviser said the Trust appears to have considered or tried every available option. Unfortunately for Miss Y, there was no other successful therapeutic option for her regardless of the level of clinical history available to the medical team.
50. We are unable to unable to see what alternative action could have been taken to prevent her death. We saw no evidence to support the view that the Trust did not obtain relevant clinical history. Miss Y’s medical records appear to have been available to the Trust before it contacted QEHB, and the purpose of that contact was not to obtain more information but to see an additional medical opinion.
Nail varnish affecting sensor readings 51. Mrs X expressed concerns that faulty readings showing inaccurately low oxygen levels may have influenced decision making, particularly regarding the decision to place her daughter in a coma.
52. We noted the Trust’s explained how it predominantly used blood gas readings to support clinical decisions. Our adviser confirmed this statement is supported by the clinical records. They said there is plenty of blood gas data in the medical records to support clinical decisions made, including the decision to intubate and ventilate. They also reviewed the readings produced by the finger sensor and the other observations used to support decisions such as the blood gas figures stated above.
53. Our adviser explained that some slight difference in readings across methods would be expected due to the differences in how oxygen saturations are measured but there is no concerning disparity between different methods. The readings from the finger sensor are consistent with the other data collected via alternative means. This indicates the finger sensor was working as it should, and not significantly affected by interference by nail varnish. We see that, while it is possible one method of obtaining clinical observations could potentially be inaccurate, it is highly unlikely that would occur across multiple other methods.
54. Our adviser also confirmed that oxygen saturation is not, by itself, a reliable indicator of respiratory failure until very late. Blood gas readings in the Intensive Care Unit (ICU) are interpreted in conjunction with other information (e.g. clinical patient observations, degree and type of respiratory support being used). In relation to this all the clinical information in Miss Y’s case consistently supports, across a range of methods, that she was suffering from respiratory failure, and her body was becoming progressively more body oxygen starved.
55. Based on the above we saw no evidence of a failure to remove nail varnish having any adverse effect on oxygen readings or clinical decision making.
Wrongly concluding leukaemia was still active and making incorrect assumptions on the cause of respiratory failure 56. Mrs X says that her daughter was cancer free following her treatment and that the stated cause of her respiratory failure was incorrect. She says her daughter only had one more chemotherapy session left, which was scheduled to keep her in remission, and no trace of the cancer cells was present.
57. Our adviser noted numerous references in the clinical notes to indicate that Miss Y was not fully in remission for her leukaemia. They said the fact that she was undergoing preventative chemotherapy supports that conclusion. While no cancer cells may be detected, this does not confirm an absence of them, only the limitations of detecting techniques. A lack of a positive result for cancer cells does not confirm an absence of them, but that they are below a level that is possible to detect with current techniques. The course of chemotherapy was, therefore, intended to keep those cells at levels below detection to prevent relapse.
58. We accept that Miss Y was in remission for her leukaemia and that Mrs X considers this to mean she was leukaemia free at the time of her final illness and so, in her view, this played no part in it. This is a different view to our adviser and is rooted in what the term ‘remission’ may mean. In our view, this is less relevant than the fact that Miss Y was receiving chemotherapy. Regardless of the reason this was provided, she suffered a virus while immune suppressed and this caused a chain of events that led to her respiratory failure. Regardless of the reason for her having chemotherapy this was a risk of that treatment.
59. Our adviser said there is no evidence to support the view that the cause of her respiratory failure was misdiagnosed. Miss Y had a diagnosis of inflammatory obliterative bronchiolitis prior to her admission. This was identified in an outpatient clinic letter of 7 June 2021. The Trust also explored, and ruled out to reasonable extents, all other potential causes in the course of trying to find a way to save Miss Y’s life.
60. Mrs X has cited a response to a complaint made to QEHB which indicates that trust considers it extremely unlikely that progressive obliterative bronchiolitis developed in the short time prior to Miss Y’s final illness. The response considered that obliterative bronchiolitis alone would not account for Miss Y’s respiratory failure. We can understand how this would have caused doubt.
61. We note that the response is answering a concern that Miss Y’s prior chemotherapy may have caused this condition. Progressive obliterative bronchiolitis indicates a variant of the disease where the lungs slowly lose function over a long period, usually many years. Our understanding of this response is it is not refuting that Miss Y suffered respiratory failure from obliterative bronchiolitis in December 2023, only that this had not been a long developing chronic condition prior to her final illness.
62. We note this is not how Miss Y’s lung function deteriorated, as this happened within days. The trigger for this was more than likely to be a sepsis causing an inflammatory response consistent with accelerating the obliterative bronchiolitis process. This caused significant damage to these organs in a short amount of time.
63. Therefore, we do not consider the complaint response from QEHB to contradict the view that obliterative bronchiolitis was the underlying reason for Miss Y’s respiratory collapse. This condition was not the sole reason for this happening as there were many elements contributing to that condition being made worse to the extent it caused respiratory failure at the time.
64. There is no evidence of anything else that could account for her lungs ceasing to transfer oxygen to her blood in such a way, so we have no reason to consider the Trust’s conclusion on this to be incorrect.
Failing to offer to suction her lungs to aid her breathing before considering an induced coma 65. Mrs X noted that her daughter’s lungs were cleared with suction after her being placed in a coma and that this should have been done prior to this to aid her breathing.
66. Our adviser said that, when a patient is not on a ventilator, chapter 2.6 of GPICS requires that provision of respiratory physiotherapy should be provided to support deep breathing and coughing (i.e. the patient is supported to clear their own lungs of any secretions). Miss Y received physiotherapy on the I C U both before, and after, intubation. We see that her treatment was in line with the relevant guidance.
67. Our adviser explained that, when a patient is intubated, suction is performed through the breathing tube, as the person is no longer able to clear their own airways. Deep respiratory suction is not a routine treatment in an un-intubated person. It would be unpleasant for the patient to attempt it and can easily make the person’s condition much worse if they are not already being maintained on a ventilator. Our adviser said there was no clinical indication to attempt it in Miss Y’s case before she was in an induced coma. There was no benefit to doing this and it would only risk harming her.
68. As stated earlier in this report, Miss Y had no difficulties in physically breathing. Her airways were not congested with any substance that could be cleared with suction. However, she was exhausted and so no longer able to sustain the effort needed to breath without mechanical aids. We see how introducing a suction tube into her lungs would only prevent her efforts to breathe and not improve them.
69. Considering our adviser’s explanations, and that guidance was correctly followed, our view is it was correct to not attempted suction prior to intubation. This would have been unnecessarily distressing and potentially harmful and have no influence on the necessity to place her in a coma.
Failing to try stronger antibiotic treatments until after placing her in a coma 70. Mrs X is concerned that using stronger antibiotics may have removed the need to place her daughter in a coma.
71. Our Adviser notes there were regular microbiology reviews and that the Trust adjusted Miss Y’s treatment based on this. She received antiviral and broad-spectrum antibiotics prior to resorting to intubation and ventilation to treat her respiratory failure. They said there were daily microbiology reviews, and this care was in line with the FICM Guidelines for the Provision of Intensive Care Services Chapter 3.5.
72. Our adviser noted that Miss Y developed intractable respiratory failure caused by obliterative bronchiolitis, probably triggered by confirmed rhinovirus infection. Antibiotics would not be effective against a virus, although antiviral treatment was given from the start of her admission to hospital. However, as her rhinovirus infection was cleared, and there was no later viral infection, it appears the antivirals had proved effective in clearing the rhinovirus.
73. Our adviser said antibiotics would help treat bacterial infection or, as here, be necessary as a precaution to prevent one due to her compromised immune system. Our adviser found no evidence to suggest she was suffering from any bacterial infection requiring an alternative antibiotic regime.
74. Based on this advice we see that Mrs X may have misunderstood the relevance, or purpose, of antibiotics in her daughter’s care. Antibiotics (and antivirals) were used to prevent her contracting any infections in the absence of her own immune system being able to do this effectively, not clear any.
75. The antibiotic regime used appears to have been fully effective. Their use was also fully in line with established guidance. Our view is that using stronger, or different, antibiotics prior to resorting to intubation would have had no effect on her daughter’s situation as this would have no beneficial impact on her respiratory failure.
Failing to correctly evaluate her Glasgow Coma Score (GCS) when considering her capacity to make decisions 76. Mrs X said that the Trust did not properly consider her daughter’s GCS when considering if she had capacity to make decisions.
77. Our adviser explained that GCS would not form part of the consideration of Miss Y’s capacity to make decisions. There is no relevant standard to apply in relation to GCS and capacity decisions. What would be relevant is her ability to receive, understand, and retain information. That said, we note that the Trust did cite GCS in its responses when explaining the decision to intubate.
78. There is ample evidence of Miss Y having capacity to make decisions, and her being considered by the Trust to have capacity. She was making decisions, and requesting her parents be present to support her. What may be relevant to note here is that the decision to intubate and ventilate was time sensitive. She was in danger of dying imminently but her ability to engage in further consenting discussions was severely compromised, rather than her ability to comprehend.
79. The Trust’s reference to GCS scores can therefore be interpreted as an attempt to explain this limited ability to communicate, and not the Trust attempting to claim she lacked capacity. In such a situation it would not be an option to delay taking action to prevent death. Miss Y’s condition would only get worse. There would be no opportunity to engage her in more meaningful consenting discussions.
80. While it is understandable that mention of GCS scores concerned Mrs X, we did not see any evidence to support the view that evaluation of her daughter’s GCS formed part of the decision to intubate her. The records indicate that she was considered to have capacity to make decisions but not considered to have capacity to engage in decision making due to her critical condition.
Damaging her lung due to failing to manage intubation correctly 81. Mrs X was concerned that her daughter’s right lung was punctured during a procedure to reposition her breathing tube.
82. While we can understand how this concern originated, as Miss Y suffered a collapsed lung around the time of her breathing tube being adjusted, the timing of this appears entirely coincidental.
83. We were unable to find any evidence to support the view that an injury was caused by an intubation tube or any other medical accident. As set out earlier in this report the medical evidence indicates Miss Y’s intubation in December 2023 was successful with no complications. The repositioning of her breathing tube several weeks later was not part of that procedure but was also without complications. We found no evidence this tube repositioning had any connection to a lung collapse that occurred on 15 January.
84. Upon reviewing the clinical evidence, our adviser was able to confirm the cause of the lung collapse. This was not due to any trauma to the lung from equipment or misuse of equipment, such as over-inflating the lungs. Due to Miss Y’s disease process, the tissues lining her right lung had deteriorated and the lining of her lung developed a leak. This led to a collapsed lung as gas entered the space around her lung.
85. Our adviser confirmed that it would not be possible for her breathing tube to have caused this to happen. They explained that a breathing tube is situated in the large airways of the lung (trachea) which lie towards the centre of the body. There was no evidence of any damage to tissues around the breathing tube at any point. There was ample evidence of inflammation and damage to the outer deep lung tissues. Our adviser said this is consistent with the underlying lung pathology of inflammatory obliterative bronchiolitis. This required ongoing positive pressure ventilation in order to keep her alive.
86. We note the perforation that led to the collapsed lung was situated in a different, outer area of the lung, far away from any area affected by breathing apparatus. As such, our view is there is no evidence of incorrect intubation or Miss Y’s lung being damaged due to any action by the Trust.
Inappropriately putting Do Not Attempt Resuscitation (DNACPR) notice in place 87. Mrs X is unhappy that a DNACPR was put in place on her daughter’s record which, she says was inappropriate to do.
88. A DNACPR was not put in place until 22 January, by which point our adviser says all clinical options had been exhausted. By this point Miss Y had been hypoxic (receiving insufficient oxygen to the bodily tissues) for a considerable length of time, and this would have consequences for her chances of survival.
89. FICM: ‘CARE AT THE END OF LIFE: A guide to best practice, discussion and decision-making in and around critical care’ guidance says:
‘Quantitative success of CPR (return of spontaneous circulation) has to be balanced against the qualitative outcome of survival. This will be affected by hypoxic brain injury and other associated long-term adverse neurological outcomes, particularly when cardiac arrest is preceded by hours of deterioration in association with severe chronic illness...DNACPR is not a signal for neglect but a means of withholding an inappropriate treatment, minimising unnecessary harm and enhancing care near the end of life.’
90. What this means in lay terms is CPR should not be attempted if it has little chance of working or, if did work, would only succeed in prolonging the patient’s suffering until the next cardiac arrest with no improvement in their chances of survival.
91. Our adviser confirmed that any attempt to bring Miss Y out of her coma was not clinically appropriate. This would not result in her returning to the condition she was in prior to being placed in a coma, but her immediate death. She was even more severely hypoxic and would not have been able to support her own breathing. Her lungs could also no longer transfer enough oxygen to her blood to sustain life without the assistance of the life support machinery (which she needed to be in a coma for).
92. Our adviser explained that what had changed by 22 January is that her disease process had continued to progress, and she had become even more gravely ill. In the event of a cardiac arrest at that point, attempting to perform CPR in this condition would have been highly likely to not be successful, and if it was, the only way to sustain her life further would be to remain in a coma state on a ventilator.
93. Our adviser confirmed that the DNACPR was put in place entirely in line with this established guidance. The key consideration in Miss Y’s case is that the cause of her illness was not curable (i.e. her state would only get worse), and CPR would have been futile at the point the DNACPR was put in place (so attempting CPR would only cause suffering and injury and have little chance of success).
94. We understand how much Mrs X would have wanted her daughter to have some chance of survival and to not give up hope. Based on the above our view is that the placing of a DNACPR was appropriate and done in the best interests of the patient. There was no possibility of any better outcome at that point. It was the right thing to do to ensure her death, when it arrived, was as dignified and free from suffering as possible by not attempting CPR.
Recorded an inaccurate cause of death on her death certificate not consistent with the clinical evidence 95. Mrs X does not accept that the cause of her daughter’s death was inflammatory obliterative bronchiolitis.
96. After carefully reviewing all the medical evidence, our adviser said the cause of death recorded is consistent with the clinical evidence in the medical records. They were also reassured that the case was discussed with the Medical Examiner and referred to the Coroner, and the Coroner accepted the cause of death as accurate. What we are seeing is that the view on what was the cause of death is consistent across all these experts.
97. We note that obliterative bronchiolitis was considered a likely factor in Miss Y’s respiratory failure from the outset by the Trust. The medical team were also aware this would be incurable, and so wished to rule out any other possible causes before conceding that there would be little that could be done to help her survive.
98. This is helpful, as it has resulted in there being ample clinical evidence to confirm the absence of any other possible cause contributing to her death. By process of elimination, this leaves inflammatory obliterative bronchiolitis as the only remaining differential diagnosis. Our current view is the recorded cause of death was not inaccurate, as it is entirely consistent with the clinical evidence.
99. Overall, having looked at reach of Mrs X’s specific concerns about care and treatment we must conclude that the Trust did provide appropriate care for her daughter’s illness, as we have found no failings. We therefore may not uphold the complaint about Miss Y not receiving appropriate care for her acute illness.