NCT05513989

Brief Summary

compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 16, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 16, 2022

Last Update Submit

August 23, 2022

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Outcome Measures

Primary Outcomes (1)

  • intubation time

    just after anesthesia induction for 30 minutes

Secondary Outcomes (4)

  • number of intubation attempts

    after anesthesia induction for 30 minutes

  • hypoxia

    after anesthesia induction for 30 minutes

  • pharyngeal trauma

    after intubation for 30 minutes

  • need for corkscrewing

    after anesthesia induction for 30 minutes

Study Arms (2)

modified Magill forceps group

ACTIVE COMPARATOR

One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation

Device: modified Magill forceps

Magill forceps group

ACTIVE COMPARATOR

One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.

Device: Magill forceps

Interventions

modified Magill forcepsDEVICE

modified pediatric Magill forceps was used to assist nasotracheal intubation.

modified Magill forceps group
Magill forcepsDEVICE

Magill forceps was used to assist nasotracheal intubation.

Magill forceps group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with the American Society of Anesthesiology physical status of 1 or 2
  • Age 4 to 8 years old.
  • Elective dental surgeries.

You may not qualify if:

  • Parental refusal to consent (absolute contraindication),
  • Patients with aspiration risk.
  • Known upper airway abnormalities.
  • Those having difficult airway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 24, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)