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Clinical Trials/NCT06655168
NCT06655168
Recruiting
Not Applicable

Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy

Tunis University1 site in 1 country115 target enrollmentDecember 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
The Time Taken for Successful Tracheal Intubation in Each Technique
Sponsor
Tunis University
Enrollment
115
Locations
1
Primary Endpoint
time taken for successful tracheal intubation
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group)

Detailed Description

prospective randomized study including newborns , requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit. The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group).

Registry
clinicaltrials.gov
Start Date
December 17, 2023
End Date
March 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tunis University
Responsible Party
Principal Investigator
Principal Investigator

Mehdi Trifa

Head of Anesthesia and Intensive Care Department

Tunis University

Eligibility Criteria

Inclusion Criteria

  • newborns requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit

Exclusion Criteria

  • age\> 01 month

Outcomes

Primary Outcomes

time taken for successful tracheal intubation

Time Frame: during intubation

Secondary Outcomes

  • the need for additional device(during intubation)
  • the number of attempts(during intubation)
  • Complications during intubation(during intubation)

Study Sites (1)

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