Skip to main content
OpenTrials
Completed

NCT Number: NCT04343014

Tongue Root Retractor For Fibroscopic Intubation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Airway Management

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tongue Root Retractor

Device

Fibroptic endutracheal intubation will be performed with tongue root retractor.

Conventional Fibroscope

Device

Fibroptic endutracheal intubation will be performed in conventional way.

Primary outcomes

  1. Feasibility of intubation.

    Time frame: 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 outcomes

  1. Epiglottis level

    Time frame: 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

  2. Carina time

    Time frame: within 90 seconds

    time from the beginning of fibroscopy to the confirmation of the carina

  3. Successful Intubation on 1st Attemp

    Time frame: from start of first intubation to end of first intubation attempt

    the success rate on 1st attempt

  4. Number of attempts for tube advancement

    Time frame: within 120 seconds

    number of attempts for tube advancement from the beginning of fibroscopy to the success of the intubation

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: TRFI

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.