Perioperative UtiLisation of SupplEmental Oxygen

NCT03552627 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: CRI0358
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

hyperoxia; oxygen; surgery; perioperative

Outcome Measures

Primary Outcomes (1)

• Total Free Thiols

  A measure of (Anti)oxidant capacity

  End of surgery

Secondary Outcomes (6)

• Other oxidative stress markers

  Within 7 days of surgery

• Acute cardiac events

  Within 7 days of surgery

• Acute Kidney Injury

  Within 7 days of surgery

• Acute Liver Injury

  Within 7 days of surgery

• Post-operative Cognitive Recovery

  7 days after surgery

Study Arms (3)

80% Oxygen

ACTIVE COMPARATOR

Patients will receive 80% oxygen throughout anaesthesia in accordance with current World Health Organisation Recommendations

Drug: Oxygen

55% Oxygen

ACTIVE COMPARATOR

Patients will receive 55% oxygen throughout anaesthesia in accordance with current UK clinical practice

Drug: Oxygen

30% Oxygen

EXPERIMENTAL

Patients will receive 30% oxygen throughout anaesthesia in accordance with this research's hypothesis that lowering intraoperative oxygen concentrations may benefit patients

Drug: Oxygen

Interventions

Oxygen DRUG

Medical Oxygen

30% Oxygen; 55% Oxygen; 80% Oxygen

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Andrew Cumpstey, BM BCh

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: March 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

GB (1)