NCT03040570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

November 21, 2016

Last Update Submit

February 22, 2018

Conditions

Critical CareHypoxiaPediatric ALL

Outcome Measures

Primary Outcomes (1)

  • Number of eligible patients recruited per site per month

    Baseline

Secondary Outcomes (24)

  • Proportion of parents/legal representatives refusing deferred consent

    Through study completion, an average of 24 hours

  • Proportion of eligible patients randomised

    Baseline

  • Distribution of time to randomisation

    Baseline

  • Proportion of systemic oxygen saturations within the target range in each group

    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)

    Through study completion, an average of 72 hours

  • +19 more secondary outcomes

Study Arms (2)

Conservative oxygenation target

EXPERIMENTAL

Children in the conservative oxygenation target group receive treatment targeting oxygen saturation values of 88-92%.

Procedure: Conservative oxygenation target

Liberal oxygenation target

ACTIVE COMPARATOR

Children in the liberal oxygenation target group receive treatment targeting oxygen saturation values of \>94%.

Procedure: Liberal oxygenation target

Interventions

Conservative oxygenation targetPROCEDURE

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).

Conservative oxygenation target
Liberal oxygenation targetPROCEDURE

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%.

Liberal oxygenation target

Eligibility Criteria

Age39 Weeks - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Great Ormond Street Hospital for Children

London, United Kingdom

Location

St Mary's Hospital

London, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 36728001DERIVED

  • 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.

    PMID: 29868973DERIVED

  • 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.

    PMID: 29247112DERIVED

MeSH Terms

Conditions

HypoxiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

February 2, 2017

Study Start

March 4, 2017

Primary Completion

June 25, 2017

Study Completion

July 1, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

GB(3)