Conservative Versus Liberal Oxygenation Targets in Critically Ill Children

Hypoxia Clinical Trial

— Oxy-PICU  

Official title:

A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040570
• Other study ID #: 15IA35
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: February 22, 2018
• Start date: March 4, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2018
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility study to determine if it is possible to perform a safe, adequately powered, and affordable multi-centre study in critically ill children comparing current practice of liberal targets for systemic oxygen levels with more conservative targets.

Description:

Around 19,000 critically ill children are admitted to paediatric intensive care units (PICU) each year in the UK. A large number of these children need breathing support, and this is usually provided through an invasive machine called a 'ventilator'. Clinicians make decisions for treatment based on how much oxygen their patient has in their blood (this is called oxygen saturation or oxygenation) and currently the amount of oxygen critically ill children need is not fully understood. This means that some clinicians use a lower oxygen saturation target, and others, a higher target. This may be problematic as research in neonates (babies) and adults has shown that oxygen saturation levels can influence a patient's chance of survival, how long they stay in hospital and healthcare costs.

Response to oxygen is different in babies, children and adults. This means that the results from the neonatal and adult research are unlikely to be valid or applicable in children due to age-related differences. Urgent high quality clinical evidence is therefore needed to inform on the best targets of oxygenation during critical illness in children.

As large clinical trials are expensive to conduct, it is important to demonstrate that a large-scale trial can be done and that the different components of a trial can all work together. Therefore, the Oxy-PICU study is a 'pilot randomised clinical trial' (a smaller version of the trial we would like to conduct) and will test the feasibility and safety of conducting a large scale trial comparing a restrictive oxygen saturation target (88-92%) with a more liberal oxygen saturation target (>94%). Oxy-PICU will also collect blood and urine samples to allow for in depth study of the biology of the different oxygenation targets.

The pilot trial will take place at three PICUs (two in London and one in Southampton) and aims to include between 115-125 eligible children over six months. Given the emergency nature of these children and the need to provide immediate care, informed consent will be sought after the children are entered into the study (this is known as deferred consent).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 1, 2017
• Est. primary completion date: June 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 39 Weeks to 15 Years

Eligibility

Inclusion Criteria:

• less than 16 years and > 38 weeks corrected gestational age

• receiving supplemental oxygen for abnormal gas exchange

• emergency admission accepted to a participating paediatric intensive care unit (PICU) requiring mechanical ventilation within first 6 hours of face-to-face contact with PICU staff or transport team

Exclusion Criteria:

• recruited to Oxy-PICU in a previous admission

• brain pathology/injury as a primary reason for admission (e.g traumatic brain injury, post-cardiac arrest, stroke, convulsive status epilepticus without aspiration)

• known pulmonary hypertension

• known or suspected sickle cell disease

• known or suspected uncorrected congenital cardiac disease

• End-of-life care plan in place with limitation of resuscitation

• not expected to survive PICU admission

• receiving long-term mechanical ventilation prior to this admission (non-invasive ventilation or invasive ventilation)

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Hypoxia
• Pediatric ALL

Intervention

Procedure:
• Conservative oxygenation target
Participants allocated to the conservative oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining 88-92% (inclusive).
• Liberal oxygenation target
Participants allocated to the liberal oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining >94%.

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children	London
United Kingdom	St Mary's Hospital	London
United Kingdom	Southampton General Hospital	Southampton

Sponsors (6)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	Intensive Care National Audit & Research Centre, St Mary's Hospital, London, University College, London, University Hospital Southampton NHS Foundation Trust, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eligible patients recruited per site per month		Baseline
Secondary	Proportion of parents/legal representatives refusing deferred consent		Through study completion, an average of 24 hours
Secondary	Proportion of eligible patients randomised		Baseline
Secondary	Distribution of time to randomisation		Baseline
Secondary	Proportion of systemic oxygen saturations within the target range in each group		Through study completion, an average of 72 hours
Secondary	Proportion of patients in each arm requiring other treatments influencing tissue oxygen delivery (blood transfusion, inotropic support)		Through study completion, an average of 72 hours
Secondary	Length of ventilation - proportion of randomised patients with outcome available in each group		Through study completion, an average of 2 days
Secondary	Length of ventilation - mean (standard deviation) in each group		Through study completion, an average of 2 days
Secondary	Length of ventilation - median and quartiles in each group.		Through study completion, an average of 2 days
Secondary	Observed adverse events		28 days
Secondary	Time taken for data collection and entry		28 days
Secondary	Measurement of ischemia-modified albumin (plasma)		72 hours
Secondary	Measurement of malondialdehyde (plasma)		72 hours
Secondary	Measurement of total antioxidant status (plasma)		72 hours
Secondary	Length of PICU stay - proportion of randomised patients with outcome available in each group		Through study completion, an average of 2 days
Secondary	Length of PICU stay - mean (standard deviation) in each group.		Through study completion, an average of 2 days
Secondary	Length of PICU stay - median and quartiles in each group.		Through study completion, an average of 2 days
Secondary	Hospital mortality - proportion of randomised patients with outcome available in each group		Through study completion, an average of 2 days
Secondary	Hospital mortality - number (percentage) in each group.		Through study completion, an average of 2 days
Secondary	PICU mortality - proportion of randomised patients with outcome available in each group		Through study completion, an average of 2 days
Secondary	PICU mortality - number (percentage) in each group.		Through study completion, an average of 2 days
Secondary	Days of organ specific support - proportion of randomised patients with outcome available in each group		Through study completion, an average of 2 days
Secondary	Days of organ specific support - mean (standard deviation) in each group		Through study completion, an average of 2 days
Secondary	Days of organ specific support - median and quartiles in each group		Through study completion, an average of 2 days
Secondary	Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes)		72 hours