Hypoxia Clinical Trial
— Oxy-PICUOfficial title:
A Randomised Pilot Multiple Centre Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children
Verified date | February 2018 |
Source | Great Ormond Street Hospital for Children NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
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 |
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 |
United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04498598 -
Structural Modification In Supraglottic Airway Device
|
N/A | |
Completed |
NCT05532670 -
N600X Low Saturation Accuracy Validation
|
||
Enrolling by invitation |
NCT04106401 -
Intravascular Volumes in Hypoxia During Antarctic Confinement
|
N/A | |
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Not yet recruiting |
NCT05817448 -
Hypoxia-induced Autophagy in the Pathogenesis of MAP
|
||
Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
Terminated |
NCT02801162 -
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
|
N/A | |
Not yet recruiting |
NCT02201875 -
Intrinsic Periodic Pattern of Breathing
|
N/A | |
Completed |
NCT02943863 -
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01922401 -
Inverse Ratio Ventilation on Bariatric Operation
|
N/A | |
Active, not recruiting |
NCT01681238 -
Goal-directed Therapy in High-risk Surgery
|
N/A | |
Completed |
NCT01463527 -
Using Capnography to Reduce Hypoxia During Pediatric Sedation
|
N/A | |
Completed |
NCT01507623 -
Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
|
N/A | |
Withdrawn |
NCT00638040 -
The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression
|
N/A | |
Active, not recruiting |
NCT06097754 -
Intermittent Exogenous Ketosis (IEK) at High Altitude
|
N/A | |
Completed |
NCT04589923 -
The VISION-Acute Study
|
||
Completed |
NCT05044585 -
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
|
N/A | |
Completed |
NCT03659513 -
The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
|
||
Completed |
NCT03221387 -
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
|
N/A |