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

• Sponsor: Suez Canal University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05455723
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.3
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Procedure: Tracheal Intubation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults
• Actual Study Start Date: Jan 19, 2022
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Inflation-Deflation Group	Procedure: Tracheal Intubation; Inflation-Deflation Technique Versus Magill Forceps Technique for Nasal Intubation by Video-assisted Laryngoscope
Active Comparator: Magill Forceps Group	Procedure: Tracheal Intubation; Inflation-Deflation Technique Versus Magill Forceps Technique for Nasal Intubation by Video-assisted Laryngoscope

Outcome Measures

Primary Outcome Measures

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. [60 seconds]

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

Secondary Outcome Measures

1. The time period for the second phase nasal intubation [60 seconds]

   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

2. The number of attempts required for successful nasal intubation. [120 seconds]

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

3. Amount of injected air for cuff inflation [15 seconds]

   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 [48 hours]

   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 [preoperative and intraoperative]

   rate of oxygen drop during the procedure

6. evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation. [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 [60 minutes]

   Need for external tracheal compression and need for help

8. need of endotracheal tube rotation [60 seconds]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suez Canal University	Ismailia		Egypt	41522

Sponsors and Collaborators

• Suez Canal University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aiman Ahmad Al-Touny, Lecturer of Anesthesia and Intensive Care, Suez Canal University
• ClinicalTrials.gov Identifier: NCT05455723
• Other Study ID Numbers: 4523#
• First Posted: Jul 13, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aiman Ahmad Al-Touny, Lecturer of Anesthesia and Intensive Care, Suez Canal University: Nasal intubation, Video-assisted Laryngoscope

Study Results

No Results Posted as of Jul 13, 2022