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

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01090726
First received: March 18, 2010
Last updated: December 10, 2010
Last verified: March 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    Succes is defined by intubation being executed in the first try.


Secondary Outcome Measures:
  • Time to Cormack evaluation [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Time to intubation [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Number of intubation attempts [ Time Frame: 5 Minutes ] [ Designated as safety issue: No ]
  • Quality of laryngeal overview before intubation [ Time Frame: 5 Minutes ] [ Designated as safety issue: No ]
    Evaluated by Cormack score

  • Prevalence of post intubation stridor [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Intubation conditions [ Time Frame: 5 Minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Month to 2 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 18, 2010
Last Updated: December 10, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on August 28, 2014