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

Difficult Airway Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325997
• Other study ID #: 20200207
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2020
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Airway Intubation
• Double-lumen Tube

Intervention

Device:
• laryngoscope with mouth opener
Double-lumen tube combined with mouth gag for laryngoscope intubation
• video laryngoscope with mouth opener
Double-lumen tube combined with mouth gag for video laryngoscope intubation

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glottis exposure time		through study completion, an average of 1 minute
Primary	Bronchial intubation time		through study completion,an average of 1 minute
Primary	The number of intubation		through study completion,an average of 1 minute
Primary	One-time success rate of intubation		through study completion,an average of 1 minute
Primary	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