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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04325997
Other study ID # 20200207
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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