Perioperative UtiLisation of SupplEmental Oxygen

Anesthesia Clinical Trial

— PULSE Ox  

Official title:

Perioperative UtiLisation of SupplEmental Oxygen

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03552627
• Other study ID #: CRI0358
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The World Health Organisation recommends that all patients having a general anaesthetic for surgery should be given 80% oxygen as this might reduce their risk of getting an infection after their operation. However there remains a lot of uncertainty about how much oxygen patients should be given whilst undergoing surgery. In other areas of medicine evidence is slowly emerging to suggest that giving less oxygen may be as safe or even safer than giving high amounts of oxygen (e.g. after a heart attack, patients unnecessarily given oxygen seem to do worse than those given air). The amount of oxygen currently given to patients having surgery varies widely; in a recent study of almost 400 procedures across 29 hospitals, we found values ranged from below 30% to almost 100% oxygen. The aim of this research is to explore if giving less oxygen will generate less strain on parts of the body, particularly the lungs as they are always exposed to all of the oxygen that enters the body. Participants undergoing major elective surgical procedures will be randomised to receive either 80%, 55% or 30% throughout their general anaesthetic and levels of inflammation, oxidative stress and perioperative recovery will all be measured for upto 7 days after surgery.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Oxygen
Medical Oxygen

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Free Thiols	A measure of (Anti)oxidant capacity	End of surgery
Secondary	Other oxidative stress markers	A panel of other markers of oxidative stress	Within 7 days of surgery
Secondary	Acute cardiac events	Elevations in troponin levels	Within 7 days of surgery
Secondary	Acute Kidney Injury	Elevations in creatinine or NGAL-1	Within 7 days of surgery
Secondary	Acute Liver Injury	Elevations in ALT	Within 7 days of surgery
Secondary	Post-operative Cognitive Recovery	PQRS score	7 days after surgery
Secondary	Postoperative Morbidity	Post Operative Morbidity Survey score	7 days after surgery