NCT05006651

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 8, 2021

Last Update Submit

August 8, 2021

Conditions

Intubation; Difficult or FailedObesity

Keywords

obesityIntubation

Outcome Measures

Primary Outcomes (2)

  • Time to Intubation

    Total intubation duration

    10 minute

  • Intubation difficulty

    Including Intubation difficulty scale, inubation attempt times, number of operator

    10 minute

Secondary Outcomes (1)

  • Any injury during intubation

    24 hours

Study Arms (3)

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

McGrath MACDEVICE

Intubaion with McGrath MAC

McGrath MAC
TrachwayDEVICE

Intubaion with Trachway

Trachway

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Hualien, 970, Taiwan

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Po-Kai Wang

    Hualien Tzu Chi General Hospital

    STUDY CHAIR

Central Study Contacts

Ching-Hsuan Huang

CONTACT

+8863-8561825velociraptor4226@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2021

First Posted

August 16, 2021

Study Start

August 4, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)