Tongue Root Retractor For Fibroscopic Intubation

Airway Management Clinical Trial

— TRFI  

Official title:

Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343014
• Other study ID #: Fibroscopic intubation
• Status: Completed
• Phase: N/A
• Start date: March 10, 2016
• Est. completion date: December 10, 2020

Study information

• Verified date: February 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study.

Patients 1) aged 18 to 70 years; 2) ASA graded I~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.

The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 10, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged 18 to 70 years

• ASA graded I~II class

• scheduled for elective surgery requiring orotracheal intubation

Exclusion Criteria:

• with organ transplant operations

• with thoracic and cardiac vascular surgery

• with severe cadiac or pulmonary disease

• BMI over 35kg/m2

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Tongue Root Retractor
Fibroptic endutracheal intubation will be performed with tongue root retractor.
• Conventional Fibroscope
Fibroptic endutracheal intubation will be performed in conventional way.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intubation.	Successs of intubation at different attempts.	From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.
Secondary	Epiglottis level	Airway clearance at the epiglottis level was assessed by observing whether the epiglottis was in contact with the posterior pharyngeal wall	within 30 seconds after the beginning of fibroscopy
Secondary	Carina time	time from the beginning of fibroscopy to the confirmation of the carina	within 90 seconds
Secondary	Successful Intubation on 1st Attemp	the success rate on 1st attempt	from start of first intubation to end of first intubation attempt
Secondary	Number of attempts for tube advancement	number of attempts for tube advancement from the beginning of fibroscopy to the success of the intubation	within 120 seconds