Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient

August 8, 2021 updated by: Buddhist Tzu Chi General Hospital
Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Hualien
      • Hualien City, Hualien, Taiwan, 970
        • Recruiting
        • Hualien Tzu Chi Hospital
        • Contact:
          • Hualien Tzu Chi Hospital
          • Phone Number: +8863-8561825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery needs intubation
  • ASA I to III
  • BMI>30kg/m2

Exclusion Criteria:

  • Head and neck cancer
  • Skull, neck fracture
  • Tracheal trauma
  • NPO< 8hr
  • Lung disease with hypoxemia
  • Mental Disorders
  • Patient wouldn't be extubated after operation immediately
  • Contraindicated to muscle relaxant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Laryngoscope
Intubation with traditional laryngoscope
Active Comparator: McGrath MAC
Intubation with video laryngoscope
Device: McGrath MAC
Intubaion with McGrath MAC
Active Comparator: Trachway
Intubation with video stylet
Device: Trachway
Intubaion with Trachway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intubation
Time Frame: 10 minute
Total intubation duration
10 minute
Intubation difficulty
Time Frame: 10 minute
Including Intubation difficulty scale, inubation attempt times, number of operator
10 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any injury during intubation
Time Frame: 24 hours
Including sore throat, hoarseness, trauma
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Investigators

  • Study Chair: Po-Kai Wang, Hualien Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

August 8, 2021

First Submitted That Met QC Criteria

August 8, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 8, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB109-265-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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