NCT03287466: TOXYC

Targeted OXYgen Therapy in Critical Illness

Completed NA Last updated 29 September 2021

What this trial tests

NA trial testing Oxygen in Critical Illness in 34 participants. Completed in 15 February 2020.

Timeline

15 January 2018

Primary endpoint
30 November 2019

15 February 2020

Quick facts

Lead sponsor	University College, London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	34
Start date	15 January 2018
Primary completion	30 November 2019
Estimated completion	15 February 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Oxygen — full drug profile →

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

University College, London

Who can join

18 and older, any sex, with Critical Illness or Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation via an endotracheal tube as part of their treatment for respiratory failure. Participants will be allocated to either a normal blood oxygen target group or a lower than normal blood oxygen target group. The primary purpose of the study will be to assess the feasibility of recruiting complex patients who lack capacity into a clinical trial in which oxygenation is being assessed, and that the clinicians responsible for these patients are able to deliver the intervention effectively. The safety of using a lower than normal blood oxygen target will also be assessed and blood samples taken for subsequent investigation of the biological mechanisms underlying the observed changes.

Participants will be randomised (1:1) into either an intervention or control group. The intervention in this trial is tightly controlled administration of oxygen to patients to achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target for the control group represents a normal SpO2, whilst that in the intervention group is lower than what is considered to be normal. It should be noted that although lower than normal, this SpO2 is close to what the general public experience when travelling by pressurised aircraft as the fractional inspired oxygen concentration in that situation is only 0.15-0.17 (15-17%).

The controlled oxygen administration would commence as soon as possible after admission to the critical care unit and end following removal of the participant's artificial breathing tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the nature of the intervention. Those analysing the data will be blinded to the intervention.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oxygen Toxicity in Critically Ill Adults.
   Hochberg CH, Semler MW, Brower RG. · · 2021 · cited 54× · PMID 34086536 · DOI 10.1164/rccm.202102-0417ci
2. Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit.
   Barbateskovic M, Schjørring OL, Russo Krauss S, Jakobsen JC, et al · · 2019 · cited 42× · PMID 31773728 · DOI 10.1002/14651858.cd012631.pub2
3. Higher versus lower fractions of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit.
   Klitgaard TL, Schjørring OL, Nielsen FM, Meyhoff CS, et al · · 2023 · cited 27× · PMID 37700687 · DOI 10.1002/14651858.cd012631.pub3
4. Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients.
   Martin DS, Brew-Graves C, McCartan N, Jell G, et al · · 2019 · cited 3× · PMID 30659035 · DOI 10.1136/bmjopen-2018-021674