Critical CareOxy-PICUNCT03040570
Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
A study testing Conservative oxygenation target and Liberal oxygenation target in people with Critical Care and Hypoxia, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 39 weeks to 15 years
- Conditions the study is for
- Critical Care, Hypoxia, Pediatric ALL
- What is being tested?
- Conservative oxygenation target and Liberal oxygenation target
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 4 Mar 2017to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 weeks to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Great Ormond Street Hospital for Children
London
St Mary's Hospital
London
Southampton General Hospital
Southampton
About this study
Official title: A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
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.
Read the 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).
- Conditions
- Critical Care, Hypoxia, Pediatric ALL
- Being tested
- Conservative oxygenation target, Liberal oxygenation target
- Medical subject headings
- Hypoxia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative oxygenation targetProcedure or surgery
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 targetProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| Conservative oxygenation target | Experimental | Children in the conservative oxygenation target group receive treatment targeting oxygen saturation values of 88-92%. Receives: Procedure: Conservative oxygenation target |
| Liberal oxygenation target | Active comparator | Children in the liberal oxygenation target group receive treatment targeting oxygen saturation values of >94%. Receives: Procedure: Liberal oxygenation target |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible patients recruited per site per month
Measured: Baseline
Secondary outcomes (24)
Proportion of parents/legal representatives refusing deferred consent
Measured: Through study completion, an average of 24 hours
Proportion of eligible patients randomised
Measured: Baseline
Distribution of time to randomisation
Measured: Baseline
Proportion of systemic oxygen saturations within the target range in each group
Measured: Through study completion, an average of 72 hours
Proportion of patients in each arm requiring other treatments influencing tissue oxygen delivery (blood transfusion, inotropic support)
Measured: Through study completion, an average of 72 hours
Length of ventilation - proportion of randomised patients with outcome available in each group
Measured: Through study completion, an average of 2 days
Length of ventilation - mean (standard deviation) in each group
Measured: Through study completion, an average of 2 days
Length of ventilation - median and quartiles in each group.
Measured: Through study completion, an average of 2 days
Observed adverse events
Measured: 28 days
Time taken for data collection and entry
Measured: 28 days
Measurement of ischemia-modified albumin (plasma)
Measured: 72 hours
Measurement of malondialdehyde (plasma)
Measured: 72 hours
Measurement of total antioxidant status (plasma)
Measured: 72 hours
Length of PICU stay - proportion of randomised patients with outcome available in each group
Measured: Through study completion, an average of 2 days
Length of PICU stay - mean (standard deviation) in each group.
Measured: Through study completion, an average of 2 days
Length of PICU stay - median and quartiles in each group.
Measured: Through study completion, an average of 2 days
Hospital mortality - proportion of randomised patients with outcome available in each group
Measured: Through study completion, an average of 2 days
Hospital mortality - number (percentage) in each group.
Measured: Through study completion, an average of 2 days
PICU mortality - proportion of randomised patients with outcome available in each group
Measured: Through study completion, an average of 2 days
PICU mortality - number (percentage) in each group.
Measured: Through study completion, an average of 2 days
Days of organ specific support - proportion of randomised patients with outcome available in each group
Measured: Through study completion, an average of 2 days
Days of organ specific support - mean (standard deviation) in each group
Measured: Through study completion, an average of 2 days
Days of organ specific support - median and quartiles in each group
Measured: Through study completion, an average of 2 days
Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start4 Mar 2017
- Primary completion25 Jun 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Intensive Care National Audit & Research Centre, University of Southampton, St Mary's Hospital, London, University Hospital Southampton NHS Foundation Trust, University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040570
- Sponsor's protocol ID
- 15IA35
- Acronym
- Oxy-PICU
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones GAL, Eaton S, Orford M, Ray S, Wiley D, Ramnarayan P, Inwald D, Grocott MPW, Griksaitis M, Pappachan J, O'Neill L, Mouncey PR, Harrison DA, Rowan KM, Peters MJ; Oxy-PICU Investigators of the Paediatric Critical Care Society Study Group (PCCS-SG). Randomization to a Liberal Versus Conservative Oxygenation Target: Redox Responses in Critically Ill Children. Pediatr Crit Care Med. 2023 Mar 1;24(3):e137-e146. doi: 10.1097/PCC.0000000000003175. Epub 2023 Jan 19.
PubMed 36728001Peters 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.
PubMed 29868973Jones 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.
PubMed 29247112
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
- ClinicalTrials.gov ID
- NCT03040570
- Acronym / sponsor ID
- Oxy-PICU / 15IA35
- Conditions
- Critical Care, Hypoxia, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Intensive Care National Audit & Research Centre, University of Southampton, St Mary's Hospital, London, University Hospital Southampton NHS Foundation Trust, University College, London
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 25 Jun 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative oxygenation target | Experimental | Procedure: Conservative oxygenation targetChildren in the conservative oxygenation target group receive treatment targeting oxygen saturation values of 88-92%. |
| Liberal oxygenation target | Active comparator | Procedure: Liberal oxygenation targetChildren in the liberal oxygenation target group receive treatment targeting oxygen saturation values of >94%. |
Who may qualify
- Ages
- 39 weeks to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative oxygenation targetParticipants 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). | Procedure or surgery | Conservative oxygenation target |
| Liberal oxygenation targetParticipants 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%. | Procedure or surgery | Liberal oxygenation target |
Primary outcome
Number of eligible patients recruited per site per month
Time frame: Baseline
24 secondary outcomes
Proportion of parents/legal representatives refusing deferred consent
Time frame: Through study completion, an average of 24 hours
Proportion of eligible patients randomised
Time frame: Baseline
Distribution of time to randomisation
Time frame: Baseline
Proportion of systemic oxygen saturations within the target range in each group
Time frame: Through study completion, an average of 72 hours
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
Length of ventilation - proportion of randomised patients with outcome available in each group
Time frame: Through study completion, an average of 2 days
Length of ventilation - mean (standard deviation) in each group
Time frame: Through study completion, an average of 2 days
Length of ventilation - median and quartiles in each group.
Time frame: Through study completion, an average of 2 days
Observed adverse events
Time frame: 28 days
Time taken for data collection and entry
Time frame: 28 days
Measurement of ischemia-modified albumin (plasma)
Time frame: 72 hours
Measurement of malondialdehyde (plasma)
Time frame: 72 hours
Measurement of total antioxidant status (plasma)
Time frame: 72 hours
Length of PICU stay - proportion of randomised patients with outcome available in each group
Time frame: Through study completion, an average of 2 days
Length of PICU stay - mean (standard deviation) in each group.
Time frame: Through study completion, an average of 2 days
Length of PICU stay - median and quartiles in each group.
Time frame: 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
Hospital mortality - number (percentage) in each group.
Time frame: Through study completion, an average of 2 days
PICU mortality - proportion of randomised patients with outcome available in each group
Time frame: Through study completion, an average of 2 days
PICU mortality - number (percentage) in each group.
Time frame: Through study completion, an average of 2 days
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
Days of organ specific support - mean (standard deviation) in each group
Time frame: Through study completion, an average of 2 days
Days of organ specific support - median and quartiles in each group
Time frame: Through study completion, an average of 2 days
Measurement of hypoxia-inducible factor-1 alpha mRNA expression (leukocytes)
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 36728001Jones GAL, Eaton S, Orford M, Ray S, Wiley D, Ramnarayan P, Inwald D, Grocott MPW, Griksaitis M, Pappachan J, O'Neill L, Mouncey PR, Harrison DA, Rowan KM, Peters MJ; Oxy-PICU Investigators of the Paediatric Critical Care Society Study Group (PCCS-SG). Randomization to a Liberal Versus Conservative Oxygenation Target: Redox Responses in Critically Ill Children. Pediatr Crit Care Med. 2023 Mar 1;24(3):e137-e146. doi: 10.1097/PCC.0000000000003175. Epub 2023 Jan 19.
- Derived from this study: PubMed 29868973Peters 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.
- Derived from this study: PubMed 29247112Jones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative oxygenation target and Liberal oxygenation target in people with Critical Care and Hypoxia, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible patients recruited per site per month (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.