NCT04325997

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 8, 2020

Last Update Submit

March 27, 2020

Conditions

Keywords

video laryngoscopdouble-lumen tubemouth gag

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (3)

an ordinary laryngos with mouth opener

EXPERIMENTAL
Device: laryngoscope with mouth opener

Video laryngoscopy intubation

NO INTERVENTION

Video laryngoscope with mouth opener

EXPERIMENTAL
Device: video laryngoscope with mouth opener

Interventions

Double-lumen tube combined with mouth gag for laryngoscope intubation

an ordinary laryngos with mouth opener

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

Video laryngoscope with mouth opener

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225012, China

Location

MeSH Terms

Interventions

Laryngoscopes

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 8, 2020

First Posted

March 30, 2020

Study Start

March 1, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

March 30, 2020

Record last verified: 2020-02

Locations