Orotracheal Intubation in Newborns: Videolaryngoscopy Vs... | NCT06655168

Studies
Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy

NCT06655168

Sponsor

Tunis University

Status

Recruiting

Last Update Posted

Oct 23, 2024Actual

Enrollment

115Estimated

Phase

Not Applicable

Conditions

The Time Taken for Successful Tracheal Intubation in Each Technique

Interventions

Video Laryngoscopy
Direct Laryngoscopy

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2023Actual

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Video laryngoscopy	Other		Device: Video Laryngoscopy
Direct laryngoscopy	Other		Device: Direct Laryngoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video Laryngoscopy	Device	orotracheal intubation by C-Mac ( Video laryngoscopy)	Video laryngoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time taken for successful tracheal intubation		during intubation

Secondary Outcomes

Measure	Description	Time Frame
the need for additional device		during intubation
the number of attempts		during intubation
Complications during intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age> 01 month

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

30 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
salma Aouadi, Hospital university assistant	Contact	0021656652210		salmaaouadi1@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bechir Hamza hospital	Recruiting	Tunis	Tunis Governorate	2001	Tunisia