Tracheal Intubation of Morbidly Obese Patients. GlideScop... | NCT00917033

Studies
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

NCT00917033

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Feb 24, 2010Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Intubation, Endotracheal
Anesthesia, General
Obesity

Interventions

GlideScope
Macintosh direct laryngoscope

Countries

Denmark

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

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 10, 2009Estimated

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

Feb 23, 2010

Last Update Posted Date

Feb 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GlideScope	Experimental	Orotracheal intubation using the GlideScope videolaryngoscope	Device: GlideScope
Macintosh	Active Comparator	Orotracheal intubation using the Macintosh direct laryngoscope	Device: Macintosh direct laryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GlideScope	Device	Orotracheal intubation	GlideScope
Macintosh direct laryngoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to intubate		Measured during intubation (seconds)

Secondary Outcomes

Measure	Description	Time Frame
Number of intubation attempts		Measured during intubation (seconds)
Lowest arterial oxygen saturation during intubation		Measured during intubation (seconds)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
Body Mass Index at least 35 kg/m2
Written informed consent to participate

Exclusion Criteria:

Mental illness
Abuse of alcohol or other substances
Previous difficult tracheal intubation
Considered non-eligible for safety-reasons by the anesthetist in charge

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lasse H Andersen, MD	Glostrup University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia, Glostrup University Hospital		Copenhagen	Glostrup	DK-2600	Denmark

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