TRFI: Tongue Root Retractor For Fibroscopic Intubation

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04343014

Collaborator

(none)

300

Enrollment

Location

Arms

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Device: Tongue Root Retractor Device: Conventional Fibroscope	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2016

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 10, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility of intubation. [From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.]
Successs of intubation at different attempts.

Secondary Outcome Measures

Epiglottis level [within 30 seconds after the beginning of fibroscopy]
Airway clearance at the epiglottis level was assessed by observing whether the epiglottis was in contact with the posterior pharyngeal wall
Carina time [within 90 seconds]
time from the beginning of fibroscopy to the confirmation of the carina
Successful Intubation on 1st Attemp [from start of first intubation to end of first intubation attempt]
the success rate on 1st attempt
Number of attempts for tube advancement [within 120 seconds]
number of attempts for tube advancement from the beginning of fibroscopy to the success of the intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04343014

Other Study ID Numbers:

Fibroscopic intubation

First Posted:

Apr 13, 2020

Last Update Posted:

Feb 10, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The First Affiliated Hospital with Nanjing Medical University

fibreoptic intubation

Study Results

No Results Posted as of Feb 10, 2021