Perioperative UtiLisation of SupplEmental Oxygen (PULSE Ox)
Study Overview
Detailed Description
Over 3 million patients receive oxygen (O2) during general anaesthesia (GA) in the UK annually, and a large number of these also have co-morbid respiratory diseases such as Asthma or COPD. The World Health Organisation (WHO) recently recommended that all surgical patients receive 80% O2 throughout GA and for 6 hours in recovery to reduce Surgical Site Infections (SSIs). However, a recent Cochrane systematic review found no evidence of benefit from this approach and some evidence that harm could be increased (including mortality).
Excess oxygen has been associated with worse outcomes in many areas of medicine (including acute respiratory illnesses), possibly due to increased Reactive Oxygen Species (ROS) production: ROS can cause oxidative stress and damage proteins, DNA, and lipids. Observational data from our group shows most surgical patients currently receive nearer 55% O2 under GA. The effect of intraoperative O2 concentration on other surgical outcomes remains unknown.
This project will determine whether giving lower concentrations of oxygen to surgical patients during anaesthesia can reduce levels of oxidative stress during surgery (particularly in the lungs); investigate how this affects other organs; and evaluate the feasibility of performing a large (multi-centre) effectiveness study to define 'safe' oxygen administration concentrations during surgery.
Patient undergoing elective major surgery will be randomised to receive 80% (WHO's recommendation); 55% (current usual care) or 30% oxygen (intervention) throughout anaesthesia. Endotracheal aspirates will be sampled along with paired central venous and arterial blood samples throughout surgery to monitor levels of oxidative stress and organ function. Patients will be followed up for 7 days after surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO16 6YD
- University Hospital Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥16yrs - no upper limit
- Undergoing elective surgical procedure
- Planned for placement of arterial line and central venous catheter as part of routine anaesthetic delivery
- Written informed consent
Exclusion Criteria:
- Withdrawal of written consent or unable to give informed written consent
- Pregnant at time of enrolment
- Neurosurgery, cardiothoracic surgery or any other operation involving 1 lung ventilation at any point during procedure
- Baseline SpO2 < 90%
- Severe COPD (3 or 4 on GOLD criteria), Interstitial lung disease or other severe respiratory inflammatory co-morbidity (including already on home oxygen)
- BMI > 35
- Assessed as having a potentially difficult airway or being difficult to ventilate (defined as concern documented at anaesthetic assessment)
- Participating in another research trial with similar interventions or outcomes.
- Sickle cell disease
- Thalassemia Major
- Under custody
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 80% Oxygen
Patients will receive 80% oxygen throughout anaesthesia in accordance with current World Health Organisation Recommendations
|
Medical Oxygen
|
|
Active Comparator: 55% Oxygen
Patients will receive 55% oxygen throughout anaesthesia in accordance with current UK clinical practice
|
Medical Oxygen
|
|
Experimental: 30% Oxygen
Patients will receive 30% oxygen throughout anaesthesia in accordance with this research's hypothesis that lowering intraoperative oxygen concentrations may benefit patients
|
Medical Oxygen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Free Thiols
Time Frame: End of surgery
|
A measure of (Anti)oxidant capacity
|
End of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Other oxidative stress markers
Time Frame: Within 7 days of surgery
|
A panel of other markers of oxidative stress
|
Within 7 days of surgery
|
|
Acute cardiac events
Time Frame: Within 7 days of surgery
|
Elevations in troponin levels
|
Within 7 days of surgery
|
|
Acute Kidney Injury
Time Frame: Within 7 days of surgery
|
Elevations in creatinine or NGAL-1
|
Within 7 days of surgery
|
|
Acute Liver Injury
Time Frame: Within 7 days of surgery
|
Elevations in ALT
|
Within 7 days of surgery
|
|
Post-operative Cognitive Recovery
Time Frame: 7 days after surgery
|
PQRS score
|
7 days after surgery
|
|
Postoperative Morbidity
Time Frame: 7 days after surgery
|
Post Operative Morbidity Survey score
|
7 days after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew Cumpstey, BM BCh, University Hospital Southampton NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CRI0358
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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