Targeted OXYgen Therapy in Critical Illness

NCT03287466 | Completed DMC

• 1 other identifier: UCL/16/0571
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Respiratory Failure

Keywords

oxygen; oxygen saturation; oxygen concentration

Outcome Measures

Primary Outcomes (1)

• Feasibility to recruit

  Ability to recruit

  15 Months

Secondary Outcomes (31)

• Measurement of arterial blood gases

  up to 21 days

• Measurement of oxygen saturation

  up to 21 days

• Measurement of fraction of inspired oxygen

  up to 21 days

• Time to extubation / detachment from mechanical ventilation

  up to 21 days

• Mechanical ventilation free days on ICU

  up to 21 days

Study Arms (2)

SpO2 88-92%

EXPERIMENTAL

The intervention is targeted oxygen therapy (TO2T) to achieve an arterial haemoglobin oxygen saturation (SpO2) of 88-92%.

Drug: Oxygen

Current best practice

ACTIVE COMPARATOR

The control group will have no specific SpO2 targets. Clinicians will be able to target SpO2 according to parameters they feel are suitable for the patient, according to standard UK practice.

Drug: Oxygen

Interventions

Oxygen DRUG

targeted oxygen therapy

Current best practice; SpO2 88-92%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unplanned admission to a critical care unit
• years of age and above (no upper age limit)
• Respiratory failure forms part of the admission diagnosis
• The patient is mechanically ventilated via an endotracheal tube
• The patient is expected to receive mechanical ventilation for \> 24 hours

You may not qualify if:

• Admission following surgery (elective or unplanned)
• Those patients expected to die within 24 hours of admission to ICU \*
• Pregnant females
• Admission post-cardiac arrest
• Admission post trauma (including traumatic brain injury)
• Known sickle cell trait or disease
• Ongoing significant haemorrhage or profound anaemia
• Severe peripheral vascular disease
• Severe pulmonary hypertension
• Other medical conditions where mild hypoxaemia would be contra-indicated \*\*\*
• Patients participating in other interventional clinical trials
• As determined by the responsible clinical team \*\* As determined by the responsible clinical team and /or research team

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Royal Free Charity: collaborator

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• Martin DS, Brew-Graves C, McCartan N, Jell G, Potyka I, Stevens J, Williams NR, McNeil M, O'Driscoll BR, Mythen M, Grocott MPW. Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients. BMJ Open. 2019 Jan 17;9(1):e021674. doi: 10.1136/bmjopen-2018-021674.

  PMID: 30659035 DERIVED

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians and other healthcare providers will not be blinded to treatment allocation, nor will the clinical research team. This is because knowing the patient's blood oxygen level is an essential component of the study. Those members of the research team analysing data after the recruitment phase of the study will be blinded to group allocation. Participants will not be blinded but are unlikely to be aware to their allocation due to the severity of their illness.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: feasibility, multi-centre, randomised controlled trial

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: September 19, 2017
• Study Start: January 15, 2018
• Primary Completion: November 30, 2019
• Study Completion: February 15, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)