- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040570
Conservative Versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU)
A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- St Mary's Hospital
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London, United Kingdom
- Great Ormond Street Hospital for Children
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Southampton, United Kingdom
- Southampton General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Conservative oxygenation target
Children in the conservative oxygenation target group receive treatment targeting oxygen saturation values of 88-92%.
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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).
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ACTIVE_COMPARATOR: Liberal oxygenation target
Children in the liberal oxygenation target group receive treatment targeting oxygen saturation values of >94%.
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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%.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of eligible patients recruited per site per month
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of parents/legal representatives refusing deferred consent
Time Frame: Through study completion, an average of 24 hours
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Through study completion, an average of 24 hours
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Proportion of eligible patients randomised
Time Frame: Baseline
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Baseline
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Distribution of time to randomisation
Time Frame: Baseline
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Baseline
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Proportion of systemic oxygen saturations within the target range in each group
Time Frame: Through study completion, an average of 72 hours
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Through study completion, an average of 72 hours
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Proportion of patients in each arm requiring other treatments influencing tissue oxygen delivery (blood transfusion, inotropic support)
Time Frame: Through study completion, an average of 72 hours
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Through study completion, an average of 72 hours
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Length of ventilation - proportion of randomised patients with outcome available in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Length of ventilation - mean (standard deviation) in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Length of ventilation - median and quartiles in each group.
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Observed adverse events
Time Frame: 28 days
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28 days
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Time taken for data collection and entry
Time Frame: 28 days
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28 days
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Measurement of ischemia-modified albumin (plasma)
Time Frame: 72 hours
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72 hours
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Measurement of malondialdehyde (plasma)
Time Frame: 72 hours
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72 hours
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Measurement of total antioxidant status (plasma)
Time Frame: 72 hours
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72 hours
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Length of PICU stay - proportion of randomised patients with outcome available in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Length of PICU stay - mean (standard deviation) in each group.
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Length of PICU stay - median and quartiles in each group.
Time Frame: Through study completion, an average of 2 days
|
Through study completion, an average of 2 days
|
Hospital mortality - proportion of randomised patients with outcome available in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Hospital mortality - number (percentage) in each group.
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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PICU mortality - proportion of randomised patients with outcome available in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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PICU mortality - number (percentage) in each group.
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Days of organ specific support - proportion of randomised patients with outcome available in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Days of organ specific support - mean (standard deviation) in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Days of organ specific support - median and quartiles in each group
Time Frame: Through study completion, an average of 2 days
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Through study completion, an average of 2 days
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Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes)
Time Frame: 72 hours
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72 hours
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Collaborators and Investigators
Publications and helpful links
General Publications
- Peters MJ, Jones GAL, Wiley D, Wulff J, Ramnarayan P, Ray S, Inwald D, Grocott M, Griksaitis M, Pappachan J, O'Neill L, Eaton S, Mouncey PR, Harrison DA, Rowan KM; Oxy-PICU Investigators for the Paediatric Intensive Care Society Study Group (PICS-SG). Conservative versus liberal oxygenation targets in critically ill children: the randomised multiple-centre pilot Oxy-PICU trial. Intensive Care Med. 2018 Aug;44(8):1240-1248. doi: 10.1007/s00134-018-5232-7. Epub 2018 Jun 4.
- Jones GAL, Ramnarayan P, Raman S, Inwald D, Grocott MPW, Eaton S, Ray S, Griksaitis MJ, Pappachan J, Wiley D, Mouncey PR, Wulff J, Harrison DA, Rowan KM, Peters MJ; Oxy-PICU Investigators for thePaediatric Intensive Care Society-Study Group (PICS-SG). Protocol for a randomised pilot multiple centre trial of conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU). BMJ Open. 2017 Dec 14;7(12):e019253. doi: 10.1136/bmjopen-2017-019253.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15IA35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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