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

Primary Purpose

Intubation; Difficult or Failed, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
McGrath MAC
Trachway
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intubation; Difficult or Failed focused on measuring obesity, Intubation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Laryngoscope

McGrath MAC

Trachway

Arm Description

Intubation with traditional laryngoscope

Intubation with video laryngoscope

Intubation with video stylet

Outcomes

Primary Outcome Measures

Time to Intubation
Total intubation duration
Intubation difficulty
Including Intubation difficulty scale, inubation attempt times, number of operator

Secondary Outcome Measures

Any injury during intubation
Including sore throat, hoarseness, trauma

Full Information

First Posted
August 8, 2021
Last Updated
August 8, 2021
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05006651
Brief Title
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
Official Title
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult or Failed, Obesity
Keywords
obesity, Intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
325 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laryngoscope
Arm Type
No Intervention
Arm Description
Intubation with traditional laryngoscope
Arm Title
McGrath MAC
Arm Type
Active Comparator
Arm Description
Intubation with video laryngoscope
Arm Title
Trachway
Arm Type
Active Comparator
Arm Description
Intubation with video stylet
Intervention Type
Device
Intervention Name(s)
McGrath MAC
Intervention Description
Intubaion with McGrath MAC
Intervention Type
Device
Intervention Name(s)
Trachway
Intervention Description
Intubaion with Trachway
Primary Outcome Measure Information:
Title
Time to Intubation
Description
Total intubation duration
Time Frame
10 minute
Title
Intubation difficulty
Description
Including Intubation difficulty scale, inubation attempt times, number of operator
Time Frame
10 minute
Secondary Outcome Measure Information:
Title
Any injury during intubation
Description
Including sore throat, hoarseness, trauma
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Hsuan Huang
Phone
+8863-8561825
Ext
14360
Email
velociraptor4226@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Kai Wang
Organizational Affiliation
Hualien Tzu Chi General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
State/Province
Hualien
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hualien Tzu Chi Hospital
Phone
+8863-8561825

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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