Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474572
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-28
Brief Title:
Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table a Randomized Crossover Manikin Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
IntTab
Brief Summary:
The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table Furthermore the success at the first attempt the intubation time and participants opinion on the procedures were investigated
This is an unblinded randomized controlled crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table
This is an unblinded randomized controlled crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table
Detailed Description:
Background Endotracheal intubation is an important life-saving procedure for critically ill neonates Some procedure-related aspects may affect the quality of the intubation Optimizing the relative height between patient and operator may improve intubation procedures
Objectives To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table Furthermore the success at the first attempt the intubation time and participants opinions on the procedures were investigated
Methods This is an unblinded randomized controlled crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table Participants will be Level III NICUPICU consultants and pediatric residents Randomization will be performed using a computer-generated random assignment list The primary outcome measure will be the forces applied on the neonatal manikin during the intubation The secondary outcome measures will be the success of the first attempt the total time of intubation and participants opinions about the procedure
Objectives To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table Furthermore the success at the first attempt the intubation time and participants opinions on the procedures were investigated
Methods This is an unblinded randomized controlled crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table Participants will be Level III NICUPICU consultants and pediatric residents Randomization will be performed using a computer-generated random assignment list The primary outcome measure will be the forces applied on the neonatal manikin during the intubation The secondary outcome measures will be the success of the first attempt the total time of intubation and participants opinions about the procedure
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