Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03908411 - The Effect of Paratracheal Pressure on the Glottic View N/A
Completed NCT04564105 - Simulation Training and Teamwork Concerning Intubation on the Icu N/A
Completed NCT02988336 - TMHT - New Method of Difficult Intubation Prediction N/A
Completed NCT03002857 - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery N/A
Recruiting NCT06337006 - Laryngeal Mask Airway Failure in Pediatric Patients
Completed NCT03443219 - RCT- LMA Supremeā„¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients N/A
Completed NCT05044416 - VieScope in Patients With an Expected Difficult Airway N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Recruiting NCT06073977 - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Enrolling by invitation NCT05055401 - Airway Management Skills Amongst Anesthesia Providers
Not yet recruiting NCT02920879 - Airway Effects of PEEP During Anesthesia Induction. N/A
Terminated NCT02644837 - AuraGain and iGel Crossover Comparison N/A
Completed NCT02263300 - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01635660 - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation N/A
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00892671 - Airway Management and Vascular Access Simulation N/A
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A