Delayed OGD 18. Mrs A says the Trust delayed carrying out a OGD scan on her sister when she was admitted to hospital between 12 March 2022 and 17 March 2022.
19. The NICE CG141 guidance outlines any patient who is over 16 and suffering with acute upper gastrointestinal bleeding should have an OGD within 24 hours of admission. Similarly the BSG guidance outlines for a patient with upper GI bleeding, clinicians should manage patients by carrying out observations, provide crystalloid fluid resuscitation (fluids to restore a patient’s volume of blood), record their Glasgow Coma Scale (GCS) score to assess a person’s level of consciousness, they should refer a patient to ensure an OGD is done within 24 hours of admission.
20. The clinical records show following Mrs C’s admission, the Trust carried out her observations which showed she had a slightly elevated pulse of 102 (normal range is between 60 and 100 beats per minute), checked her blood pressure which was 76/42 which was low (normal blood pressure is between 90/60 and 120/80) and checked her blood count which was low at 82g/L (normal range is 115-150 g/L for women). The Trust provided her crystalloid fluid, recorded her GCS and referral her for an OGD.
21. In its SIR, the Trust acknowledged it delayed the OGD by five days. This is not in line with NICE CG141 and BSG guidance of carrying out an OGD within 24 hours of admission, or the clinical advice we have received. We consider this to be a failing.
22. Having identified this failing, we have carefully considered the impact this had on Mrs C.
23. Mrs A considers ultimately the delay caused her sister’s death, which she feels was avoidable. We are truly sorry to hear Mrs A has concerns that the care the Trust provided caused her sister’s death. We understand how important this issue is for her.
24. We requested clinical advice to help us establish and explain what impact, if any, we think this delay had on Mrs C. We have also looked to establish if there could have been a different outcome for Mrs C if the OGD had been done within 24 hours of her admission, as Mrs A claims.
25. Our adviser explains it is difficult for us to easily measure the risks of increased mortality (death) or a second rebleed with the type of delay Mrs C experienced. They explain the only studies available in these circumstances to help us determine what the impact was, look at the risk of mortality with a maximum delayed OGD by 48 hours and the relevant risks associated with a delay of this amount of time. Our adviser could not find any studies which look at delays longer than this.
26. The Guo C et al study we reference, found the risk of mortality, rebleed and need for intensive care admission for all people who presented to hospital with a bleed to be 4.3% with an OGD performed between six and 24 hours following admission, this increased to 5.8% when the OGD was performed between 24 and 48 hours.
27. The Rockall et al study we reference found that when an OGD is done within 24 hours for people with the same risk score as Mrs C it carries a 24.1% risk of rebleeding, with an associated mortality rate of 10.8%. This means that even if Mrs C's OGD had been performed in the timeframe it should have been, without any delay, there was still a 10.8% risk of mortality.
28. From the evidence provided, we think it is reasonable to say the longer the delay, the higher the risk of mortality. Yet, our adviser could not find any data on mortality rates after any longer delay.
29. We have not seen evidence to help us reach a view even on the balance of probabilities, on how the failings we have identified impacted Mrs C’s chances of survival. The Rockall et al publication tells us that even if Mrs C had the OGD sooner it may have resulted in the same outcome, as there was still a 24.1% chance she would have had a rebleed and a 10.8% mortality risk.
30. Our adviser importantly explains that as Mrs C had been referred for further haematological investigations by her GP in January 2022, this meant she may have had an underlying illness or condition that was not yet investigated and diagnosed. If this was the case, our adviser said even if the OGD had been done within 24 hours, Mrs C's rebleeding risk would have increased to 43.8%, with a 27% risk of mortality.
31. We have considered the evidence and studies above, the significant impact of the rebleed on Mrs C, and that she was deemed to have suffered a haemodynamic compromise, (when a person’s cardiovascular functions become unreliable).
32. Taking this into account, we think on the balance of probabilities, it is more likely Mrs C would not have had a stroke if she had not had the rebleed from her stomach ulcer, and our clinical advice supports this view.
33. And yet, as we have explained above, Mrs C's risk of a rebleed was high, even without there being any delay in her OGD. This makes it difficult for us to establish what actual impact the delayed OGD had on Mrs C.
34. Taking the evidence into consideration, our adviser explains even if Mrs C had the OGD sooner, there is still a chance she would have had a rebleed from her ulcer and sadly died. This means we cannot say, even on balance Mrs C would not have suffered a rebleed from her ulcer, if the OGD had gone ahead as it should have done, within 24 hours from admission.
35. Our adviser explains there is not enough evidence available for us to be able to reach the decision, even on balance that Mrs C would not have died if she had the OGD within 24 hours. We would therefore unable to ever find that Mrs C’s death was avoidable as Mrs A has suggested.
36. We recognise this will be very distressing for Mrs A to read particularly as this involves a careful consideration of published medical data and percentages of risk. To make clear we cannot say the delay had no impact on the very sad outcome. Equally we cannot say Mrs C would not have died, even if she had the OGD in time.
37. Ultimately we will never know or be able to say even on balance to what extent the delay impacted on Mrs C, or if there even was any. We therefore cannot say with certainty there was any link between the delay, and Mrs A’s overall claimed injustice, that the delay caused her sister’s death, which she feels was avoidable. We understand that never knowing what the impact to her sister was, caused Mrs A distress and upset. We recognise how difficult this must be for her.
38. Mrs A is requesting an apology, service improvements and a financial remedy as an outcome of her complaint. We have considered this request carefully. We can see in its SIR, the Trust has identified the key failing in this case, namely the delay in completing the OGD following Mrs C’s admission. The Trust has apologised for the delay, provided an explanation as to what happened and created two actions in response to the delay identified, to ensure inpatient OGD’s are a part of the OGD list and triaged depending on the patient’s condition, and ensuring any delayed OGD’s are escalated to a consultant if not resolved. We are reassured to see the Trust has taken this issue seriously.
39. We have considered whether the Trust has taken sufficient action in response to the delayed OGD by considering these actions against the Principles. The Principles outline how we consider there are a wide range of remedies including an apology, explanation and action to prevent the same thing from happening again. The actions taken by the Trust are in line with the Principles.
40. We have also asked our adviser to review the actions taken by the Trust, to ensure they are sufficient from a clinical point of view. Our adviser explains the Trust has correctly identified the key failing during the admission, provided an explanation as to why this may have happened. They consider the Trust has taken important and relevant clinical action to address this to prevent this failing from happening again in the future.
41. Overall we are satisfied the Trust has taken appropriate action in respect of the delayed OGD in line with the Principles, and our clinical advice supports this view. For this reason, we do not consider any further recommendations are required in relation to this complaint.
42. We are pleased to see the Trust has taken this concern very seriously and has created important service improvements with the aim of preventing this from happening again. We understand how difficult the complaints process has been for Mrs A and why the complaint is so important for her. We hope our findings provide Mrs A with reassurances over the Trust’s investigation into her complaint.
Treatment 43. Mrs A says the Trust failed to appropriately treat her sister for a bleed in her stomach and a stomach ulcer during her admission.
44. The ESGE guidance outlines patients who suffer a stomach bleed and/or stomach ulcer should be treated with endoscopic thermal therapy (a medical procedure to treat various conditions in the gastrointestinal tract). They should be provided with intravenous (IV) fluids to maintain their hydration and if they are hemodynamically unstable (insufficient blood flow in the body), be considered for transfer to a high dependency unit for further treatment or monitoring. Acid suppression is recommended for 72-hours after the bleed.
45. The clinical records show the Trust suspected Mrs C had suffered a stomach bleed on 17 March after she was vomiting blood and had low blood pressure. The Trust started the OGD under general anaesthetic at 11.45am, during the OGD it was identified Mrs C had a large stomach ulcer but felt she was not actively bleeding in her stomach at the time. The Trust requested a surgeon attend the operating theatre, who treated Mrs C with endoscopic gold probe thermal therapy, which uses heat through an endoscope to treat an ulcer. Our adviser explains this was reasonable in the circumstances and would have reduced the risk of any further bleeding, which can sometimes occur after this type of treatment. This treatment of endoscopic thermal therapy was in line with the ESGE guidance.
46. Our adviser explains this treatment appears to be successful and there is no evidence to suggest Mrs C suffered a further bleed in her stomach after this because we can see on the post-mortem report after her sad death, there was no evidence of any blood present in Mrs C’s stomach.
47. After the procedure the Trust transferred Mrs C to the HDU so she could be monitored further for any further bleeding. Our adviser explains during her time in the HDU the Trust provided Mrs C with appropriate fluids to maintain her hydration and IV antibiotics to treat any potential infection. We can also see the Trust prescribed and administered Mrs C a high-dose IV omeprazole, which was used for acid suppression treatment. We consider this treatment in HDU was in line with the ESGE guidance.
48. Overall we consider the Trust appropriately treated Mrs C’s bleed in the stomach and stomach ulcer and our clinical advice supports this view.
Nil by mouth 49. Mrs A says the Trust inappropriately kept her sister nil by mouth between 13 March and 16 March 2022.
50. The NHS page on OGD outlines that prior to the procedure, patients need to stop eating at least six hours before the procedure. They may be able to have small sips of water prior to the procedure taking place.
51. Our adviser explains it is essential prior to undertaking an OGD procedure that patients are kept nil by mouth.
52. The clinical records show the Trust kept Mrs C nil by mouth on a daily basis between 13 March and 16 March 2022 in preparation for her OGD procedure, this is because on each day the Trust expected the procedure to take place.
53. We can see on 13 March the Trust kept Mrs C nil by mouth until 5.17pm when the Trust allowed Mrs C to eat and drink as normal. On 14 March the Trust kept her nil by mouth until 6.15pm, when it provided food and drink and one litre of IV fluid. On 15 March the Trust kept her nil by mouth until 11.29am, after this the Trust allowed Mrs C to eat and drink as normal. On 16 March the Trust kept her nil by mouth until 6.45pm and provided her with three litres of IV fluid.
54. We requested clinical advice to establish whether the time the Trust kept Mrs C nil by mouth during this period was appropriate. Our adviser considers the time Mrs C was kept nil by mouth until on both 13 March and 16 March was not ideal in the circumstances, as it was clear on these days that the procedure was not going ahead. Therefore our adviser said the Trust should have allowed her to eat earlier than it did.
55. Our adviser explains during this period the Trust did however treat Mrs C appropriately with fluids to maintain her hydration. Specifically we can see the Trust provided Hartmann’s solution (a solution used to replace fluids and electrolytes in people who have low blood pressure) on 16 March to manage her low blood pressure at the time. They explain the blood tests from this period give no suggestion that Mrs C was dehydrated during this time.
56. Taking this into consideration, while it may have been more appropriate to allow Mrs C to eat and drink as normal sooner than it did on 14 and 16 March, we cannot say the failure to do so amounts to maladministration, as we consider the Trust appropriately treated her during this time to maintain her hydration given her reduction in nutrition. Overall we have not seen any evidence to suggest the decision to keep Mrs C nil by mouth at times during her admission amounts to maladministration.
57. We understand Mrs A’s strength of feeling in respect of the decision to keep her sister nil by mouth during this period and acknowledge how difficult it must have been to see her not eating during this time.
58. We are truly sorry to hear of Mrs A’s concerns in respect of the care and treatment provided to her sister. We understand how important this complaint is for her and it is clear from speaking to her how much of an impact this continues to have on her. We extend our sincere condolences to her for her sister’s death.