Hypoxia Clinical Trial
Official title:
FIRST-ABC Feasibility Study: Feasibility Study for a Randomised Trial of High Flow Nasal Cannula (HFNC) Versus Continuous Positive Airway Pressure (CPAP) for Non-invasive Respiratory Support in Critically Ill Children
A feasibility study to inform the design and conduct of a randomised controlled trial of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in critically ill children
Breathing support is the most common intervention provided to critically ill children in a
paediatric intensive care unit (PICU). Although invasive breathing support (delivered
through a tracheal tube) is lifesaving, concerns regarding its risks (infection and lung
damage) have prompted greater use of non-invasive respiratory support (NRS). However, there
is little scientific evidence to guide PICU clinicians on the comparative effectiveness of
the commonly used modes of NRS.
In this feasibility study, the investigators are testing whether it is possible to conduct a
randomised clinical trial comparing two modes of NRS: continuous positive airway pressure
(CPAP), which has been used for over two decades, and high flow nasal cannula (HFNC), a
newer method of respiratory support. It is not known for sure how useful HFNC is in
critically ill children because there is no published research comparing it with CPAP.
However, since HFNC is easier to use and better tolerated by children, many hospitals are
now using HFNC instead of CPAP. Before HFNC is widely adopted, a clinical trial to establish
its role in the management of critically ill children is urgently needed.
As part of this study, the investigators will randomly allocate children deemed to require
NRS by their treating clinician to either HFNC or CPAP. The investigators will mainly assess
whether sufficient number of children can be recruited to the trial, whether clinicians are
willing to randomise children, and test the proposed treatment pathways for CPAP and HFNC.
The trial will run over six months, and recruit 120 sick children from three National Health
Service (NHS) hospitals. Consent will be sought from parents/guardians for their children to
be included in the study, usually before CPAP or HFNC is started, unless emergency
life-saving treatment is required, in which case consent will be deferred until there is
more time to discuss the study with parents/guardians.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 | |
Completed |
NCT02943863 -
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
|
N/A | |
Not yet recruiting |
NCT02201875 -
Intrinsic Periodic Pattern of Breathing
|
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 |