Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy

NCT ID: NCT06655168

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-17

Study Completion Date

2025-03-31

Brief Summary

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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

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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).

Conditions

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The Time Taken for Successful Tracheal Intubation in Each Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Video laryngoscopy

Group Type OTHER

Video Laryngoscopy

Intervention Type DEVICE

orotracheal intubation by C-Mac ( Video laryngoscopy)

Direct laryngoscopy

Group Type OTHER

Direct Laryngoscopy

Intervention Type DEVICE

Orotracheal intubation using Direct Laryngoscopy

Interventions

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Video Laryngoscopy

orotracheal intubation by C-Mac ( Video laryngoscopy)

Intervention Type DEVICE

Direct Laryngoscopy

Orotracheal intubation using Direct Laryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age\> 01 month
Minimum Eligible Age

1 Minute

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tunis University

OTHER

Sponsor Role lead

Responsible Party

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Mehdi Trifa

Head of Anesthesia and Intensive Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bechir Hamza hospital

Tunis, Tunis Governorate, Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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salma Aouadi, Hospital university assistant

Role: CONTACT

0021656652210

Facility Contacts

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salma Aouadi

Role: primary

0021656652210

Other Identifiers

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212023

Identifier Type: -

Identifier Source: org_study_id

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