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Active, Not Recruiting

NCT Number: NCT03552627

Perioperative UtiLisation of SupplEmental Oxygen

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

Medical Oxygen

Primary outcomes

  1. Total Free Thiols

    Time frame: End of surgery

    A measure of (Anti)oxidant capacity

Secondary outcomes

  1. Other oxidative stress markers

    Time frame: Within 7 days of surgery

    A panel of other markers of oxidative stress

  2. Acute cardiac events

    Time frame: Within 7 days of surgery

    Elevations in troponin levels

  3. Acute Kidney Injury

    Time frame: Within 7 days of surgery

    Elevations in creatinine or NGAL-1

  4. Acute Liver Injury

    Time frame: Within 7 days of surgery

    Elevations in ALT

  5. Post-operative Cognitive Recovery

    Time frame: 7 days after surgery

    PQRS score

  6. Postoperative Morbidity

    Time frame: 7 days after surgery

    Post Operative Morbidity Survey score

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Acronym: PULSE Ox

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2018
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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