Mcgrath Videolaryngoscope Versus Macintosh Laryngoscope i... | NCT03516539

Studies
Mcgrath Videolaryngoscope Versus Macintosh Laryngoscope in Patients With Manual In-line Stabilization

NCT03516539

Sponsor

Hallym University Medical Center

Status

Unknown status

Last Update Posted

May 4, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Anesthesia, General

Interventions

Group ML
Group DL

Countries

South Korea

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

Apr 2018

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

Dec 11, 2017Actual

Primary Completion Date

Jun 30, 2018Estimated

Completion Date

Jul 7, 2018Estimated

First Submitted Date

Apr 24, 2018

First Submission Date that Met QC Criteria

Apr 24, 2018

First Posted Date

May 4, 2018Actual

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

Apr 24, 2018

Last Update Posted Date

May 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade.

Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.

Detailed Description

In the operating room, all patients are monitored with an electrocardiograph, noninvasive blood pressure, pulse oximeter, capnograph and Bispectral index (BIS) monitor. After pre-oxygenation with 100% oxygen for 1 minute, intravenous anesthesia (TIVA) with propofol and remifentanyl is administrated and followed by rocuronium (0.6mg/kg). When patients are lost their consciousness, manual mask ventilation is proceeded with 100% oxygen for 2 minutes.
Transoral endotracheal intubation is performed using Mcgrath videolaryngoscope (Group ML) and direct laryngoscope (Group DL) using manual in-line stabilization. At this time, the time required for intubation is measure by other medical personnel not engaged in this research.
The anesthesiologist assesses Cormack Lehane laryngeal visual field,external laryngeal manipulation, intubation difficulty scales (IDS) and the difficulty of intubation.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group ML	Experimental	Mcgrath videolaryngoscopy	Device: Group ML
Group DL	Active Comparator	direct Macintosh laryngoscope	Device: Group DL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group ML	Device	Mcgrath videolaryngoscope	Group ML
Group DL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intubation success rate	success or failure of intubation	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Time required for intubation	time until end tidal carbon dioxide (CO2) measurement after laryngeal blade passing through patient's teeth	1 hour
Intubation difficulty score	difficulty at the time of intubation. (easy /moderate/ difficult)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.

Exclusion Criteria:

Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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
Yi Hwa Choi, Dr.	Contact	82-31-380-3813	9346	pcyhchoi@hallym.or.kr

Overall Officials

Name	Affiliation	Role
Yi Hwa Choi, Dr	Halllym university Sacred Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital	Recruiting	Anyang-si	Gyeonggi-do	14068	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15601274	Background	Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.
12846635	Background	Asai T, Murao K, Shingu K. Training method of applying pressure on the neck for laryngoscopy: use of a videolaryngoscope. Anaesthesia. 2003 Jun;58(6):602-3. doi: 10.1046/j.1365-2044.2003.03207_7.x. No abstract available.