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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04343014
Other study ID # Fibroscopic intubation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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