A Comparison of Cervical Spine Movement During Tracheal I... | NCT01347151

Studies
A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope

NCT01347151

Sponsor

Prince of Songkla University

Status

Unknown status

Last Update Posted

May 4, 2011Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

C-spine Movement During Intubation

Interventions

The glidescope video laryngoscopy
The Pentax airwayscope

Countries

Thailand

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

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

May 2, 2011

First Submission Date that Met QC Criteria

May 3, 2011

First Posted Date

May 4, 2011Estimated

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

May 3, 2011

Last Update Posted Date

May 4, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view with minimal cervical spine movement. This study wants to compare cervical spine movement during intubation when using these two devices. The C-spine motion will be recorded by using fluoroscopic video to measure the angular displacement of the vertebrae.

Detailed Description

The primary outcome is the angular displacement of the vertebrae and secondary outcome is the hemodynamic changes after 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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glide scope	Experimental		Device: The glidescope video laryngoscopy
Pentax airway scope	Experimental		Device: The Pentax airwayscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The glidescope video laryngoscopy	Device		Glide scope
The Pentax airwayscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the angular displacement of the vertebrae	during intubation	30 seconds

Secondary Outcomes

Measure	Description	Time Frame
the hemodynamic changes after intubation.	after intubation	15 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-III
Age 18-75 years old
Elective noncardiac surgery requiring general anesthesia with tracheal intubation

Exclusion Criteria:

Gastroesophageal reflux disease
Body mass index greater than 35 kg/m2
Possibility of pregnancy
Previous neck surgery
Unstable C-spine/ C-spine abnormality
Known difficult airway
Suspected difficult airway

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nalinee Kovitwanawong, MD	Depatment of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Songklanagarind Hospital		Hat Yai	Changwat Songkhla	90110	Thailand