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

• Sponsor: Buddhist Tzu Chi General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05006651
• Collaborator: (none)
• Enrollment: 325
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 9.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation; Difficult or Failed; Obesity	Device: McGrath MAC; Device: Trachway	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 325 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
• Actual Study Start Date: Aug 4, 2021
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to Intubation [10 minute]

   Total intubation duration

2. Intubation difficulty [10 minute]

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

Secondary Outcome Measures

1. Any injury during intubation [24 hours]

   Including sore throat, hoarseness, trauma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hualien Tzu Chi Hospital	Hualien City	Hualien	Taiwan	970

Sponsors and Collaborators

• Buddhist Tzu Chi General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Buddhist Tzu Chi General Hospital
• ClinicalTrials.gov Identifier: NCT05006651
• Other Study ID Numbers: IRB109-265-A
• First Posted: Aug 16, 2021
• Last Update Posted: Aug 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Buddhist Tzu Chi General Hospital: obesity; Intubation
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Aug 16, 2021