Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364280
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-09
Brief Title:
Pediatric Prehospital Airway Resuscitation Trial
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Pediatric Prehospital Airway Resuscitation Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Pedi-PART
Brief Summary:
This study is a Phase 3 multi-center Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children Emergency Medical Services EMS agencies affiliated with the Pediatric Emergency Care Applied Research Network PECARN will participate in the trial The study interventions are strategies of prehospital airway management BVM-only BVM followed by SGA and BVM followed by ETI The primary outcome is 30-day ICU-free survival The trial will be organized and executed in two successive stages In Stage I of the trial EMS personnel will alternate between two strategies BVM-only or BVM followed by SGA The winner of Stage I will advance to Stage II based upon results of Bayesian interim analyses In Stage II of the trial EMS personnel will alternate between BVM followed by ETI vs Winner of Stage I
Detailed Description:
Cardiac arrest respiratory failure and major trauma are devastating critical conditions in children Resuscitation from critical illness requires skillful airway management to optimize the delivery of oxygen to the lungs preventing irreparable damage to the brain and heart As the first to provide resuscitation care for critically ill children prehospital EMS personnel are often the first to perform life-saving airway management
The most common prehospital airway management techniques bag-valve-mask ventilation BVM endotracheal intubation ETI and supraglottic airway insertion SGA have important trade-offs between risks and benefits Despite the challenges of ETI and national recommendations favoring BVM many EMS personnel favor ETI over BVM Newer SGA devices such as the laryngeal tube LT laryngeal mask airway LMA and i-gel have not been compared with other techniques in children National organizations including the Agency for Healthcare Research and Quality have declared the need for new rigorous trials of all techniques to determine the best strategies for prehospital airway management in children Interviews with front-line EMS personnel underscore the dire need for clear and strategic guidelines for managing the pediatric airway
The Pediatric Prehospital Airway Resuscitation Trial Pedi-PART will determine the best strategies for prehospital airway management in critically ill children The trial aims are Aim I-Primary Objective Effectiveness-Stage I Determine if BVM-only or BVM followed by SGA results in better ICU-free survival in critically ill children with cardiac arrest major trauma or respiratory failure Stage II Determine if winner of Stage I or BVM followed by ETI results in better ICU-free survival Bayesian analyses will determine the transition from Stage I to Stage II ensuring optimal deployment of available subjects to address the postulated questions Aim 2- Secondary Objective Safety-Stage I Determine if BVM followed by SGA results in fewer prehospital and hospital safety events compared with BVM-only in critically ill children with cardiac arrest major trauma or respiratory failure Stage II Determine if the winner of Stage I results in fewer safety events compared with BVM followed by ETI
The trial will use a Bayesian Adaptive Sequential Comparison Platform Trial BASiC-PT design and will be executed in two sequential stages Stage I Determine if BVM-only or BVM followed by SGA results in better ICU-free survival in critically ill children with cardiac arrest major trauma or respiratory failure Stage II Determine if winner of Stage I or BVM followed by ETI results in better ICU-free survival Bayesian analyses will determine the transition from Stage I to Stage II ensuring optimal deployment of available subjects to address the postulated questions
The most common prehospital airway management techniques bag-valve-mask ventilation BVM endotracheal intubation ETI and supraglottic airway insertion SGA have important trade-offs between risks and benefits Despite the challenges of ETI and national recommendations favoring BVM many EMS personnel favor ETI over BVM Newer SGA devices such as the laryngeal tube LT laryngeal mask airway LMA and i-gel have not been compared with other techniques in children National organizations including the Agency for Healthcare Research and Quality have declared the need for new rigorous trials of all techniques to determine the best strategies for prehospital airway management in children Interviews with front-line EMS personnel underscore the dire need for clear and strategic guidelines for managing the pediatric airway
The Pediatric Prehospital Airway Resuscitation Trial Pedi-PART will determine the best strategies for prehospital airway management in critically ill children The trial aims are Aim I-Primary Objective Effectiveness-Stage I Determine if BVM-only or BVM followed by SGA results in better ICU-free survival in critically ill children with cardiac arrest major trauma or respiratory failure Stage II Determine if winner of Stage I or BVM followed by ETI results in better ICU-free survival Bayesian analyses will determine the transition from Stage I to Stage II ensuring optimal deployment of available subjects to address the postulated questions Aim 2- Secondary Objective Safety-Stage I Determine if BVM followed by SGA results in fewer prehospital and hospital safety events compared with BVM-only in critically ill children with cardiac arrest major trauma or respiratory failure Stage II Determine if the winner of Stage I results in fewer safety events compared with BVM followed by ETI
The trial will use a Bayesian Adaptive Sequential Comparison Platform Trial BASiC-PT design and will be executed in two sequential stages Stage I Determine if BVM-only or BVM followed by SGA results in better ICU-free survival in critically ill children with cardiac arrest major trauma or respiratory failure Stage II Determine if winner of Stage I or BVM followed by ETI results in better ICU-free survival Bayesian analyses will determine the transition from Stage I to Stage II ensuring optimal deployment of available subjects to address the postulated questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24HL165014 | NIH | None | httpsreporternihgovquickSearchU24HL165014 |
| UG3HL165019 | NIH | None | None |