NCT06655168

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

October 22, 2024

Last Update Submit

October 22, 2024

Conditions

The Time Taken for Successful Tracheal Intubation in Each Technique

Keywords

endotracheal intubation, newborn, direct laryngoscopy,video laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • time taken for successful tracheal intubation

    during intubation

Secondary Outcomes (3)

  • the need for additional device

    during intubation

  • the number of attempts

    during intubation

  • Complications during intubation

    during intubation

Study Arms (2)

Video laryngoscopy

OTHER
Device: Video Laryngoscopy

Direct laryngoscopy

OTHER
Device: Direct Laryngoscopy

Interventions

Video LaryngoscopyDEVICE

orotracheal intubation by C-Mac ( Video laryngoscopy)

Video laryngoscopy
Direct LaryngoscopyDEVICE

Orotracheal intubation using Direct Laryngoscopy

Direct laryngoscopy

Eligibility Criteria

Age1 Minute - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • age\> 01 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

RECRUITING

Central Study Contacts

salma Aouadi, Hospital university assistant

CONTACT

0021656652210salmaaouadi1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia and Intensive Care Department

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 23, 2024

Study Start

December 17, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations

TU(1)