Tongue Root Retractor For Fibroscopic Intubation

NCT04343014 | Completed DMC

• 1 other identifier: Fibroscopic intubation
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

fibreoptic intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Epiglottis level

  within 30 seconds after the beginning of fibroscopy

• Carina time

  within 90 seconds

• Successful Intubation on 1st Attemp

  from start of first intubation to end of first intubation attempt

• Number of attempts for tube advancement

  within 120 seconds

Study Arms (2)

Tongue Root Retractor

EXPERIMENTAL

Patients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors.

Device: Tongue Root Retractor

Conventional Fibroscope

ACTIVE COMPARATOR

Patients in this arm will receive fibroscopic endotracheal intubation without any other devices.

Device: Conventional Fibroscope

Interventions

Tongue Root Retractor DEVICE

Fibroptic endutracheal intubation will be performed with tongue root retractor.

Tongue Root Retractor

Conventional Fibroscope DEVICE

Fibroptic endutracheal intubation will be performed in conventional way.

Conventional Fibroscope

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 to 70 years
• ASA graded I\~II class
• scheduled for elective surgery requiring orotracheal intubation

You may not qualify if:

• with organ transplant operations
• with thoracic and cardiac vascular surgery
• with severe cadiac or pulmonary disease
• BMI over 35kg/m2

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Study Officials

• Zhengnian Ding, M.D.

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: April 13, 2020
• Study Start: March 10, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 10, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

CN (1)