Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults

NCT05455723 | Recruiting

• 1 other identifier: 4523#
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare cuff inflation deflation method versus conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial that need nasal intubation. The study question: Is cuff inflation deflation method for nasal intubation takes a short time than the conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial? We will compare the inflation deflation technique with the Magill forceps technique for nasal intubation in adult patients to see if the inflation deflation technique will take less time and associated with less side effects like cuff perforation and mucosal injury. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Conditions

Airway Management; Nasal Intubation; Video Laryngoscope

Keywords

Magill forceps; Inflation-deflation technique; Video-assisted Laryngoscope; Nasal intubation

Outcome Measures

Primary Outcomes (1)

• The time period for the second phase of nasal intubation

  The time in seconds for the second phase nasal intubation(from the tip of endotracheal tube will be placed in pharynx till it pass the vocal cords

  Intraoperaotive

Secondary Outcomes (8)

• to test whether the inflation-deflation method would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach.

  Intraoperaotive

• The number of attempts required for successful nasal intubation.

  Intraoperaotive

• Amount of injected air for cuff inflation

  Intraoperaotive

• Assessment of side effects of using Magill forceps during nasal intubation

  Intraoperaotive

• Evaluation of oxygenation state during nasal intubation

  preoperative and intraoperative

Study Arms (2)

Inflation-Deflation Group

ACTIVE COMPARATOR

Group A (45 patients): Phase 2 of ETT intubation will be performed with tracheal tube cuff inflation-deflation method. Tracheal tube cuff will be inflated with 15-20 ml of air (volume of air is depending on the level of larynx). Once the tip of ETT at the laryngeal inlet, the cuff of ETT will be deflated and advanced into the trachea.

Procedure: Inflation-deflation technique

Magill Forceps Group

ACTIVE COMPARATOR

Group B (45 patients): Phase 2 of ETT intubation will be performed using the Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.

Procedure: Magill forceps technique

Interventions

Inflation-deflation technique PROCEDURE

Inflation-Deflation Technique: The tracheal tube cuff will be inflated with 15-20 ml of air (volume of air is depending on the level of larynx). Once the tip of ETT at the laryngeal inlet, the cuff of ETT will be deflated and advanced into the trachea.

Inflation-Deflation Group

Magill forceps technique PROCEDURE

The Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.

Magill Forceps Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.

You may not qualify if:

• Patients, who have coagulopathies,
• Have upper airway abnormalities,
• At risk for aspiration or by reasons of
• Parent's refusal will be excluded from the study

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

RECRUITING

Study Officials

• Tarek F. Tammam, Professor

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek F. Tammam, Professor

CONTACT

00201280871947; tarek1367@hotmail.com

Aiman A. Al-Touny, Lecturer

CONTACT

00201008185785; aimantouny@med.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The nasal intubation will be performed behind an opaque screen so that observer could not see which approach will be used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 13, 2022
• Study Start: January 19, 2024
• Primary Completion: February 25, 2025
• Study Completion: March 31, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)