NCT06300437

Brief Summary

In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

March 3, 2024

Last Update Submit

August 1, 2025

Conditions

Keywords

fiberopticintubationchildrentraining

Outcome Measures

Primary Outcomes (1)

  • time to successful endotracheal tube insertion

    time to successful endotracheal tube insertion (defined as time from face mask removal until direct visualization of the ETT in the trachea by the fiberscope after sliding of the ETT over the fiberscope).

    3 minutes

Secondary Outcomes (2)

  • Number of attempts to successful intubation

    3 minutes

  • Complication

    3 minutes

Study Arms (2)

Group jaw thrust

EXPERIMENTAL

will include the children who will receive jaw thrusting during fiberoptic intubation.

Procedure: jaw thrust

Group control

ACTIVE COMPARATOR

will include the children who will not receive jaw thrusting (just sub laxed open mouth)

Procedure: control (sub laxed jaw)

Interventions

jaw thrustPROCEDURE

children who will receive jaw thrusting during fiberoptic intubation

Group jaw thrust

children who will not receive jaw thrusting (just sub laxed open mouth)

Group control

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children more than 1-year of age
  • American Society of Anesthesiologists physical status I-II
  • scheduled for elective surgery under general anesthesia.

You may not qualify if:

  • Patients known or suspected difficult intubation.
  • Patients with syndrome known to be associated with difficult intubation.
  • Patients with severe pulmonary or cardiac diseases.
  • Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM).
  • Body mass index (BMI) greater than 35 kg/m2.
  • Refusal of the patient guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

Study Officials

  • Khaled Sarhan

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In this study, children undergoing elective surgery under general anesthesia will be randomized into 2 groups. * Group (J): will include the children who will receive jaw thrusting during fiberoptic intubation. * Group (C): will include the children who will not receive jaw thrusting (just sub laxed open mouth)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Asst. professor of anesthesia, Cairo university

Study Record Dates

First Submitted

March 3, 2024

First Posted

March 8, 2024

Study Start

March 3, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

August 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations