Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

December 10, 2010 updated by: Rigshospitalet, Denmark
The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation.
  • Informed consent from parent.
  • The parents must have legal custody of the child.
  • The parents must be able to read and understand Danish.

Exclusion Criteria:

  • Expected difficult airway.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Storz videolaryngoscope
Macintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation.
Device: Storz videolaryngoscope
Storz videolaryngoscope being used for the actual intubation
Active Comparator: Airtraq
Macintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation.
Device: Airtraq
Airtraq being used for the actual intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 5 minutes
Succes is defined by intubation being executed in the first try.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Cormack evaluation
Time Frame: 5 minutes
5 minutes
Time to intubation
Time Frame: 5 minutes
5 minutes
Number of intubation attempts
Time Frame: 5 Minutes
5 Minutes
Quality of laryngeal overview before intubation
Time Frame: 5 Minutes
Evaluated by Cormack score
5 Minutes
Prevalence of post intubation stridor
Time Frame: 12 hours
12 hours
Intubation conditions
Time Frame: 5 Minutes
5 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 19, 2010

First Posted (Estimate)

March 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 13, 2010

Last Update Submitted That Met QC Criteria

December 10, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 1A-INF-STORZ-AIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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