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NCT Number: NCT05455723

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].

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, 41522, Egypt

Location status: Recruiting

Location contact

Aiman A. Al-Touny, Lecturer

SUB_INVESTIGATOR

Ghada A. Kamhawy, Assis. Professor

SUB_INVESTIGATOR

Shimaa A. Dahshan, Lecturer

SUB_INVESTIGATOR

Tarek F. Tammam, Professor

CONTACT

[email protected]

00201280871947

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Magill forceps technique

Procedure

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

Primary outcomes

  1. The time period for the second phase of nasal intubation

    Time frame: Intraoperaotive

    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

Secondary outcomes

  1. 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.

    Time frame: Intraoperaotive

    The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.

  2. The number of attempts required for successful nasal intubation.

    Time frame: Intraoperaotive

    number of trials, how many numbers of attempts the investigator take for successful nasal intubation

  3. Amount of injected air for cuff inflation

    Time frame: Intraoperaotive

    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

  4. Assessment of side effects of using Magill forceps during nasal intubation

    Time frame: Intraoperaotive

    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)

  5. Evaluation of oxygenation state during nasal intubation

    Time frame: preoperative and intraoperative

    rate of oxygen drop during the procedure

  6. evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.

    Time frame: 20 minutes after patient recovery

    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

  7. Need for external compression and need for help

    Time frame: Intraoperaotive

    Need for external tracheal compression and need for help

  8. need of endotracheal tube rotation

    Time frame: Intraoperaotive

    need of endotracheal tube rotation and the degree of rotation 90, 180 0r 360 degree

Study contacts

Contact information is provided by the study sponsor or research team.

Aiman A. Al-Touny, Lecturer

CONTACT

[email protected]

00201008185785

Tarek F. Tammam, Professor

CONTACT

[email protected]

00201280871947

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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