Tongue Root Retractor For Fibroscopic Intubation (TRFI)

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: Tongue Root Retractor; Device: Conventional Fibroscope

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tongue Root Retractor; Patients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors.	Device: Tongue Root Retractor; Fibroptic endutracheal intubation will be performed with tongue root retractor.
Active Comparator: Conventional Fibroscope; Patients in this arm will receive fibroscopic endotracheal intubation without any other devices.	Device: Conventional Fibroscope; Fibroptic endutracheal intubation will be performed in conventional way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Carina time	time from the beginning of fibroscopy to the confirmation of the carina	within 90 seconds
Successful Intubation on 1st Attemp	the success rate on 1st attempt	from start of first intubation to end of first intubation attempt
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Zhengnian Ding, M.D., The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Xiaofei Cao, M.D., The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Junbei Wu, M.D., The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: October 8, 2017
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: fibreoptic intubation
• Other Study ID Numbers: Fibroscopic intubation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No