Applicaion of Mouth Opener Combined With Electronic Video Laryngoscope in Double-lumen Intubation of Patients With Difficult Airway

How to quickly expose glottis and accurately insert double luminal tracheal tube in patients with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia induction.This study through the double cavity bronchial tube visual laryngoscope intubation with open mouth and electronic video laryngoscope used in combination, to explore whether can shorten the glottis exposure, improve the success rate of the double lumen tube intubation will reduce pharyngeal damage, reduce intubation hemodynamic fluctuations, in order to improve the glottis appeared difficult patients with bronchial intubation success rate to provide the reference.

Study Overview

• Status: Completed
• Conditions: Difficult Airway Intubation; Double-lumen Tube
• Intervention / Treatment: Device: laryngoscope with mouth opener; Device: video laryngoscope with mouth opener

Detailed Description

A total of 60 patients who needed double-lumen endobronchial catheterization in thoracic department and whose Arne o 'risk index score was at least 7 points were randomly divided into three groups.Group B was intubated with video laryngoscopy.Group C was intubated with a mouth opener for video laryngoscope combined with a double-lumen bronchial tube for video laryngoscope intubation (hereinafter referred to as the mouth opener).The glottis exposure time, bronchial intubation time, intubation times, success rate of one intubation, and NRS score of pharyngeal pain 8 hours after surgery were observed and recorded in the three groups, and the hemodynamic changes after intubation were observed and recorded.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225012
      • the Affiliated Hospital of Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of early lung cancer
• Ages ranged from 30 to 80

Exclusion Criteria:

• Pregnancy
• Prediction of difficulty in mask ventilation
• Chest X-ray examination of trachea, bronchial anatomical abnormalities or tumor compression caused by trachea/bronchial deformation
• Failure of assessing Arne risk index

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: an ordinary laryngos with mouth opener	Device: laryngoscope with mouth opener; Double-lumen tube combined with mouth gag for laryngoscope intubation
No Intervention: Video laryngoscopy intubation
Experimental: Video laryngoscope with mouth opener	Device: video laryngoscope with mouth opener; Double-lumen tube combined with mouth gag for video laryngoscope intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glottis exposure time		through study completion, an average of 1 minute
Bronchial intubation time		through study completion,an average of 1 minute
The number of intubation		through study completion,an average of 1 minute
One-time success rate of intubation		through study completion,an average of 1 minute
Glottic field grading	Cormack-Lehane grading, C-L1：Can see glottis mostly；C-L2：Only the posterior union of the glottis is visible, not the glottis, and at most the cartilago arytaenoidea is visible when the larynx is lightly pressed；C-L3： can't see any part of the glottis, only the epiglottis； C-L4：No part of the larynx can be seen	through study completion,an average of 1 minute

Collaborators and Investigators

• Sponsor: Zhuan Zhang

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: February 8, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: double-lumen tube; mouth gag; video laryngoscop
• Other Study ID Numbers: 20200207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No