Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-31 @ 12:22 AM
Study NCT ID:
NCT03194503
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tracheal Intubation Coaching in NICUs
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs
Status:
COMPLETED
Status Verified Date:
2021-03
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:
None
Brief Summary:
The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.
Detailed Description:
Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs).Recently, video laryngoscopy (VL) has become available in neonatal clinical practice to allows trainees and frontline providers to perform standard direct airway visualization (i.e., traditional laryngoscopy) while the supervisor can simultaneously view a real-time video displaying what the laryngoscopist is seeing. However, VL associated coaching during TI has not been rigorously evaluated.The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs. The primary objective of this study is to determine whether the video coaching skill training for neonatology attendings reduces the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years before and after intervention. The secondary objectives are to 1) determine if video coaching training is feasible to all neonatology attending physicians using train the trainer approach with a remote simulation and 2) determine if the video coaching skill competency among neonatology attending physicians who completed the training using a remote simulation
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21HD089151-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |