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

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].

Study Overview

• Status: Recruiting
• Conditions: Airway Management; Nasal Intubation; Video Laryngoscope
• Intervention / Treatment: Procedure: Inflation-deflation technique; Procedure: Magill forceps technique

Detailed Description

Magill forceps is used to maneuver the endotracheal tube (ETT) in the posterior oropharynx and place its tip into the laryngeal inlet. While the Magill forceps are useful in guiding the nasotracheal tube past the vocal cords, care must be taken to avoid excessive maneuvering in order to minimize the risk of local trauma and rupture of the nasotracheal tube balloon.

Cuff inflation-deflation method can reduce the apnea time in the adult patients. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.

Written informed consent will be obtained from all patients participating in the trial. The trial will be registered prior to patient enrollment. Ninety patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I -II , scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospective randomized observer blinded clinical trial. Patients, who have coagulopathies, have upper airway abnormalities, at risk for aspiration or patient's refusal will be excluded from the study.

Materials and methods

Airway management is subdivided into phases:

Phase 1 :Passage of the endotracheal tube through the nose into the pharynx Phase 2 : Video-laryngoscope-guided passage of the endotracheal tube through the pharynx into the trachea.

Patients will be randomized into 2 groups according to phase 2:

Group A (45 patients) 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.

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

Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed outside the study center by means of a computer generated random- numbers table. Group allocation will be concealed in sealed opaque envelopes that will not be opened till the last practical moment.

The nasal intubation will be performed behind an opaque screen so that observer could not see which approach will be used. All procedures were performed preoperatively by the attending anesthetists, who have the same substantial expertise (at least 3 years) in the video laryngoscopy assisted nasal intubation in adult patients. Patient demographics, type and duration of surgery, and the patient's ASA physical status will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tarek F. Tammam, Professor; Phone Number: 00201280871947; Email: tarek1367@hotmail.com
• Study Contact Backup: Name: Aiman A. Al-Touny, Lecturer; Phone Number: 00201008185785; Email: aimantouny@med.suez.edu.eg

Study Locations

• Egypt
  • Ismailia, Egypt, 41522
    • Recruiting
    • Suez Canal University
    • Contact: Tarek F. Tammam, Professor; Phone Number: 00201280871947; Email: tarek1367@hotmail.com
    • Contact: Aiman A. Al-Touny, Lecturer
    • Contact: Shimaa A. Dahshan, Lecturer
    • Contact: Ghada A. Kamhawy, Assis. Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inflation-Deflation Group; 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; 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.
Active Comparator: Magill Forceps Group; 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; The Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of oxygenation state during nasal intubation	rate of oxygen drop during the procedure	preoperative and intraoperative
evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.	score 1 to 5 A five-point Likert scales for: How likely is it that anesthetist would recommend the same used inflation-deflation method to practice a colleague in the future (not at all/ slightly/ moderately/ very/ extremely: where 1 is not at all, 3 is moderate,5 is extremely	20 minutes after patient recovery
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.	The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.	Intraoperaotive
The number of attempts required for successful nasal intubation.	number of trials, how many numbers of attempts the investigator take for successful nasal intubation	Intraoperaotive
Amount of injected air for cuff inflation	Amount of injected air in ml, how many air injected in the cuff balloon to make the tip of endotracheal tube advanced into the trachea	Intraoperaotive
Assessment of side effects of using Magill forceps during nasal intubation	A 4-point scale: 1- No epistaxis; 2-Mild epistaxis (blood on the tracheal tube only); 3- Moderate epistaxis (blood pooling in the pharynx); 4- Severe epistaxis (blood in the pharynx sufficient to impede intubation)	Intraoperaotive
Need for external compression and need for help	Need for external tracheal compression and need for help	Intraoperaotive
need of endotracheal tube rotation	need of endotracheal tube rotation and the degree of rotation 90, 180 0r 360 degree	Intraoperaotive

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: Tarek F. Tammam, Professor, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 10, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Nasal intubation; Magill forceps; Inflation-deflation technique; Video-assisted Laryngoscope
• Other Study ID Numbers: 4523#

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
• product manufactured in and exported from the U.S.: No