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Perioperative UtiLisation of SupplEmental Oxygen

Study acronym: PULSE Ox
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Dec 2021 to Dec 2026 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 39 to confirmed 28 · Completion date: Jan 2022 to Dec 2026 · 1 morev5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 39 to confirmed 28
    • Completion date: Jan 2022 to Dec 2026
    • Site details revised
  2. Notable Primary completion date: Mar 2020 to Dec 2021 Completion date: Apr 2020 to Jan 2022v4 Show 1 more changeShow less
    • Completion date: Apr 2020 to Jan 2022
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Secondary endpoints: details revised at 1 of 6 entriesv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03552627
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Conditions Anesthesia
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov