NCT00917033

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

1.1 years

First QC Date

June 9, 2009

Last Update Submit

February 23, 2010

Conditions

Intubation, EndotrachealAnesthesia, GeneralObesity

Outcome Measures

Primary Outcomes (1)

  • Time to intubate

    Measured during intubation (seconds)

Secondary Outcomes (8)

  • Number of intubation attempts

    Measured during intubation (seconds)

  • Lowest arterial oxygen saturation during intubation

    Measured during intubation (seconds)

  • Subjective difficulty of intubation

    Measured during intubation (seconds)

  • Cormack-Lehane Score

    Measured during intubation (seconds)

  • Airway mucosal trauma

    Measured during intubation (seconds)

  • +3 more secondary outcomes

Study Arms (2)

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

GlideScopeDEVICE

Orotracheal intubation

GlideScope
Macintosh direct laryngoscopeDEVICE

Orotracheal intubation

Macintosh

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Glostrup University Hospital

Copenhagen, Glostrup, DK-2600, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lasse H Andersen, MD

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

September 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

DK(1)