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Completed

NCT Number: NCT04325997

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.

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Key information

Conditions

Difficult Airway Intubation Double-Lumen Tube

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225012, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laryngoscope with mouth opener

Device

Double-lumen tube combined with mouth gag for laryngoscope intubation

video laryngoscope with mouth opener

Device

Double-lumen tube combined with mouth gag for video laryngoscope intubation

Primary outcomes

  1. Glottis exposure time

    Time frame: through study completion, an average of 1 minute

  2. Bronchial intubation time

    Time frame: through study completion,an average of 1 minute

  3. The number of intubation

    Time frame: through study completion,an average of 1 minute

  4. One-time success rate of intubation

    Time frame: through study completion,an average of 1 minute

  5. Glottic field grading

    Time frame: through study completion,an average of 1 minute

    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

Sponsors and collaborators

Lead sponsor

Zhuan Zhang

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2020
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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