Modified Magill Forceps Facilitating Nasal Intubation for Children Undergoing Dental Operations

August 23, 2022 updated by: RAMY AHMED, Ain Shams University
compare between Magill forceps and modified pediatric Magill forceps for nasotracheal intubation (which method is easier and better?).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

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

For each patient, intubation time, number of intubation attempts, hypoxia (recognized when oxygen saturation decreases below 94%), pharyngeal trauma, and need for corkscrewing will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 20
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: modified Magill forceps group
One hundred and ten patients for whom modified pediatric Magill forceps was used to assist nasotracheal intubation
Device: modified Magill forceps
modified pediatric Magill forceps was used to assist nasotracheal intubation.
ACTIVE_COMPARATOR: Magill forceps group
One hundred and ten patients for whom Magill forceps was used to assist nasotracheal intubation.
Device: Magill forceps
Magill forceps was used to assist nasotracheal intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intubation time
Time Frame: just after anesthesia induction for 30 minutes
just after anesthesia induction for 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
number of intubation attempts
Time Frame: after anesthesia induction for 30 minutes
after anesthesia induction for 30 minutes
hypoxia
Time Frame: after anesthesia induction for 30 minutes
after anesthesia induction for 30 minutes
pharyngeal trauma
Time Frame: after intubation for 30 minutes
after intubation for 30 minutes
need for corkscrewing
Time Frame: after anesthesia induction for 30 minutes
after anesthesia induction for 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (ACTUAL)

August 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00006379 MMF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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