Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183827
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-05
Brief Title:
Drowning-related Acute Respiratory Failure
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Evaluation of Non-Invasive VentilationContinuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPAPDROWNING
Brief Summary:
The purpose of this study is to assess the Non-Invasive Ventilation-Continuous Positive Airway Pressure efficacy experimental group for drowning related Acute Respiratory Failure compared to Oxygen Supply by face mask 15Litersminutes control group
Detailed Description:
Open-label multicenter prospective cross-over cluster randomized ratio 11 conducted in 16 Emergency Medical Service centers in France
Experimental group Non-Invasive Ventilation-Continuous Positive Airway Pressure Arm 1
Control group Oxygen Supply by face mask Arm 2
Drowning-related acute respiratory failure has important clinical consequences 4 to 18 mortality No nationalinternational medical consensus exist for its management
Our team has successively demonstrated that
The acute respiratory failure related to drowning in salt or fresh water presented the same clinical pathway and prognosis
Most victims with drowning related acute respiratory failure do no present hemodynamic instability
If the oxygenation is rapidly improved neurological status is also maintained in acute respiratory failure victims
Pediatric and adult presentations are similar
Facing an acute respiratory failure emergency medical service must rapidly choose between oxygen supply by face mask 15 liters minutes mechanical ventilation or non-invasive ventilation mechanical ventilation as non-invasive ventilation present interests and side arms No comparative study has been conducted between these strategies The arguments for non-invasive ventilation use specifically in a continuous positive airway pressure mode are
Fast recovery of acute respiratory failure in 24h
Retrospective publications showing that the benefit of non-invasive ventilation probably based on continuous positive airway pressure mode
Easy implementation of continuous positive airway pressure in the pre-hospital setting adults children newborns
Complexity of mechanical ventilation in pre-hospital setting Our working hypothesis is the efficacy of early use of non-invasive ventilation-continuous positive airway pressure in drowning related acute respiratory failure
Experimental group Non-Invasive Ventilation-Continuous Positive Airway Pressure Arm 1
Control group Oxygen Supply by face mask Arm 2
Drowning-related acute respiratory failure has important clinical consequences 4 to 18 mortality No nationalinternational medical consensus exist for its management
Our team has successively demonstrated that
The acute respiratory failure related to drowning in salt or fresh water presented the same clinical pathway and prognosis
Most victims with drowning related acute respiratory failure do no present hemodynamic instability
If the oxygenation is rapidly improved neurological status is also maintained in acute respiratory failure victims
Pediatric and adult presentations are similar
Facing an acute respiratory failure emergency medical service must rapidly choose between oxygen supply by face mask 15 liters minutes mechanical ventilation or non-invasive ventilation mechanical ventilation as non-invasive ventilation present interests and side arms No comparative study has been conducted between these strategies The arguments for non-invasive ventilation use specifically in a continuous positive airway pressure mode are
Fast recovery of acute respiratory failure in 24h
Retrospective publications showing that the benefit of non-invasive ventilation probably based on continuous positive airway pressure mode
Easy implementation of continuous positive airway pressure in the pre-hospital setting adults children newborns
Complexity of mechanical ventilation in pre-hospital setting Our working hypothesis is the efficacy of early use of non-invasive ventilation-continuous positive airway pressure in drowning related acute respiratory failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None