Adult patients undergoing elective major abdominal surgery Surgery
Conditions
Interventions
The master protocol for this study is registered at https://www.isrctn.com/ISRCTN14639555
Eligible patients will be approached for consent before surgery. If consented their baseline and demographic
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 50 years and over undergoing elective major abdominal surgery, using open, laparoscopic or robotic surgical technique
Exclusion criteria
Exclusion criteria: 1. Inability or refusal to provide informed consent 2. Anticipated requirement for invasive or non-invasive respiratory support for at least 4 hours after surgery as part of routine clinical care 3. Previous enrolment in the PROTECT-HFNO comparison 4. Clinician refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient outcome measures: 1.Postoperative pulmonary complications within 30 days after surgery, a composite outcome comprising: pneumonia, Acute Respiratory Distress Syndrome and/or Pulmonary Aspiration. 2.Re-intubation within 30 days after surgery. 3.DAH30 4.All complications graded by Clavien-Dindo within 30 days of surgery 5.Mortality within 30 days of surgery 6.Duration of hospital stay (number of days from day or surgery until hospital discharge) within 30 days after surgery 7.Compliance with HFNO, including duration delivered and any reasons for discontinuation 8.Adverse events associated within HFNO within 12 hours from end of surgery Hospital level outcome measures: 1.Number of eligible patients per year in each hospital 2.Number of patients consented per year in each hospital 3.Included hospital randomising at least one patient within the 12-month recruitment period 4.Number of consultant surgeons and anaesthetists in each hospital who support recruitment of the patients in their care in principle as a proportion of those delivering care for elective major abdominal surgery 5.Number of consultant surgeons and anaesthetists in each hospital who do not support recruitment of the patients in their care in principle as a proportion of those delivering care for elective major abdominal surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures as this is a feasibility study | — |
Countries
England, United Kingdom
Contacts
Public ContactBecky Dodds
Outcome results
None listed