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

March 18, 2010
December 10, 2010
March 2010
October 2010   (final data collection date for primary outcome measure)
Success rate [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Succes is defined by intubation being executed in the first try.
Same as current
Complete list of historical versions of study NCT01090726 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Intubation
  • Videolaryngoscopy
  • Infant
  • Device: Storz videolaryngoscope
    Storz videolaryngoscope being used for the actual intubation
  • Device: Airtraq
    Airtraq being used for the actual intubation
  • Experimental: Storz videolaryngoscope
    Macintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation.
    Intervention: Device: Storz videolaryngoscope
  • Active Comparator: Airtraq
    Macintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation.
    Intervention: Device: Airtraq
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
1 Month to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01090726
1A-INF-STORZ-AIR
No
Martin Kryspin Soerensen/ MD, Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP