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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090726
First Posted: March 22, 2010
Last Update Posted: December 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention
Intubation Videolaryngoscopy Infant Device: Storz videolaryngoscope Device: Airtraq

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Success rate [ Time Frame: 5 minutes ]
    Succes is defined by intubation being executed in the first try.


Secondary Outcome Measures:
  • Time to Cormack evaluation [ Time Frame: 5 minutes ]
  • Time to intubation [ Time Frame: 5 minutes ]
  • Number of intubation attempts [ Time Frame: 5 Minutes ]
  • Quality of laryngeal overview before intubation [ Time Frame: 5 Minutes ]
    Evaluated by Cormack score

  • Prevalence of post intubation stridor [ Time Frame: 12 hours ]
  • Intubation conditions [ Time Frame: 5 Minutes ]

Estimated Enrollment: 10
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090726


Locations
Denmark
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Kryspin Soerensen/ MD, Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
ClinicalTrials.gov Identifier: NCT01090726     History of Changes
Other Study ID Numbers: 1A-INF-STORZ-AIR
First Submitted: March 18, 2010
First Posted: March 22, 2010
Last Update Posted: December 13, 2010
Last Verified: March 2010