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

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455723
• Other study ID #: 4523#
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2022
• Source: Suez Canal University
• Contact: Tarek F. Tammam, Professor
• Phone: 00201280871947
• Email: tarek1367[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

Procedure:
• Tracheal Intubation
Inflation-Deflation Technique Versus Magill Forceps Technique for Nasal Intubation by Video-assisted Laryngoscope

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 seconds
Secondary	The time period for the second phase 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	60 seconds
Secondary	The number of attempts required for successful nasal intubation.	number of trials, how many numbers of attempts the investigator take for successful nasal intubation	120 seconds
Secondary	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	15 seconds
Secondary	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)	48 hours
Secondary	Evaluation of oxygenation state during nasal intubation	rate of oxygen drop during the procedure	preoperative and intraoperative
Secondary	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
Secondary	Need for external compression and need for help	Need for external tracheal compression and need for help	60 minutes
Secondary	need of endotracheal tube rotation	need of endotracheal tube rotation and the degree of rotation 90, 180 0r 360 degree	60 seconds