NCT01827085

Brief Summary

The purpose of the study is to investigate wether the use of the Stortz video laryngoscope will render in shorter time for the intubation of obese patients compared with the use of a conventional Macintosh laryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

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

May 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

3.3 years

First QC Date

March 26, 2013

Last Update Submit

October 6, 2016

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

  • Time to intubation seconds (s)

    Up to 1 minute

Secondary Outcomes (4)

  • Presence and level of postoperational throat pain

    1 hour to 96 hours postoperative

  • Ease of intubation

    Two minutes

  • Incidence of trauma in each group

    Two minutes

  • Number of attempts of intubation

    Two minutes

Study Arms (2)

Macintosh laryngoscope

Patients will be intubated with a conventional Machintosh laryngoscope

Device: Conventional Macintosh laryngoscope

Videolaryngoscope

Intubation with Stortz video laryngoscope

Device: Stortz videolaryngoscope

Interventions

Conventional Macintosh laryngoscopeDEVICE
Macintosh laryngoscope
Stortz videolaryngoscopeDEVICE
Videolaryngoscope

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

In-patients from the University hospital of Orebro who will go through planned surgery

You may qualify if:

  • Age 18-60
  • Obesity defined as BMI \> 35
  • ASA 1-3

You may not qualify if:

  • known or suspected difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaethesia and Intensive Care, University Hospital Örebro

Örebro, 70351, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 26, 2013

First Posted

April 9, 2013

Study Start

May 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

SE(1)