Video Laryngoscope vs. Video Stylet During General Anesth... | NCT05006651

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

NCT05006651

Sponsor

Buddhist Tzu Chi General Hospital

Status

Unknown status

Last Update Posted

Aug 16, 2021Actual

Enrollment

325Estimated

Phase

Not Applicable

Conditions

Intubation; Difficult or Failed
Obesity

Interventions

McGrath MAC
Trachway

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 4, 2021Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Jul 31, 2024Estimated

First Submitted Date

Aug 8, 2021

First Submission Date that Met QC Criteria

Aug 8, 2021

First Posted Date

Aug 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2021

Last Update Posted Date

Aug 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

325Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laryngoscope	No Intervention	Intubation with traditional laryngoscope
McGrath MAC	Active Comparator	Intubation with video laryngoscope	Device: McGrath MAC
Trachway	Active Comparator	Intubation with video stylet	Device: Trachway

Interventions

Name	Type	Description	Arm Group Labels	Other Names
McGrath MAC	Device	Intubaion with McGrath MAC	McGrath MAC
Trachway

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ching-Hsuan Huang	Contact	+8863-8561825	14360	velociraptor4226@gmail.com

Overall Officials

Name	Affiliation	Role
Po-Kai Wang	Hualien Tzu Chi General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hualien Tzu Chi Hospital	Recruiting	Hualien City	Hualien	970	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided