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Conservative Versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU)

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ClinicalTrials.gov Identifier: NCT03040570
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Intensive Care National Audit & Research Centre
University of Southampton
St Mary's Hospital, London
University Hospital Southampton NHS Foundation Trust
University College, London
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Critical Care Hypoxia Pediatric ALL Procedure: Conservative oxygenation target Procedure: Liberal oxygenation target Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Actual Study Start Date : March 4, 2017
Actual Primary Completion Date : June 25, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Conservative oxygenation target
Children in the conservative oxygenation target group receive treatment targeting oxygen saturation values of 88-92%.
 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).
Active Comparator: Liberal oxygenation target
Children in the liberal oxygenation target group receive treatment targeting oxygen saturation values of >94%.
 Procedure: 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%.


Outcome Measures
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Primary Outcome Measures :
  1. Number of eligible patients recruited per site per month [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Proportion of parents/legal representatives refusing deferred consent [ Time Frame: Through study completion, an average of 24 hours ]
  2. Proportion of eligible patients randomised [ Time Frame: Baseline ]
  3. Distribution of time to randomisation [ Time Frame: Baseline ]
  4. Proportion of systemic oxygen saturations within the target range in each group [ Time Frame: Through study completion, an average of 72 hours ]
  5. 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 ]
  6. Length of ventilation - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  7. Length of ventilation - mean (standard deviation) in each group [ Time Frame: Through study completion, an average of 2 days ]
  8. Length of ventilation - median and quartiles in each group. [ Time Frame: Through study completion, an average of 2 days ]
  9. Observed adverse events [ Time Frame: 28 days ]
  10. Time taken for data collection and entry [ Time Frame: 28 days ]
  11. Measurement of ischemia-modified albumin (plasma) [ Time Frame: 72 hours ]
  12. Measurement of malondialdehyde (plasma) [ Time Frame: 72 hours ]
  13. Measurement of total antioxidant status (plasma) [ Time Frame: 72 hours ]
  14. Length of PICU stay - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  15. Length of PICU stay - mean (standard deviation) in each group. [ Time Frame: Through study completion, an average of 2 days ]
  16. Length of PICU stay - median and quartiles in each group. [ Time Frame: Through study completion, an average of 2 days ]
  17. Hospital mortality - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  18. Hospital mortality - number (percentage) in each group. [ Time Frame: Through study completion, an average of 2 days ]
  19. PICU mortality - proportion of randomised patients with outcome available in each group [ Time Frame: Through study completion, an average of 2 days ]
  20. PICU mortality - number (percentage) in each group. [ Time Frame: Through study completion, an average of 2 days ]
  21. 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 ]
  22. Days of organ specific support - mean (standard deviation) in each group [ Time Frame: Through study completion, an average of 2 days ]
  23. Days of organ specific support - median and quartiles in each group [ Time Frame: Through study completion, an average of 2 days ]
  24. Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes) [ Time Frame: 72 hours ]

Eligibility Criteria
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Ages Eligible for Study:   39 Weeks to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040570


Locations
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United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
St Mary's Hospital
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Intensive Care National Audit & Research Centre
University of Southampton
St Mary's Hospital, London
University Hospital Southampton NHS Foundation Trust
University College, London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03040570    
Other Study ID Numbers: 15IA35
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory