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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090726
• Other study ID #: 1A-INF-STORZ-AIR
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: December 10, 2010
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: March 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 2 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant
• Intubation
• Videolaryngoscopy

Intervention

Device:
• Storz videolaryngoscope
Storz videolaryngoscope being used for the actual intubation
• Airtraq
Airtraq being used for the actual intubation

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Succes is defined by intubation being executed in the first try.	5 minutes	No
Secondary	Time to Cormack evaluation		5 minutes	No
Secondary	Time to intubation		5 minutes	No
Secondary	Number of intubation attempts		5 Minutes	No
Secondary	Quality of laryngeal overview before intubation	Evaluated by Cormack score	5 Minutes	No
Secondary	Prevalence of post intubation stridor		12 hours	No
Secondary	Intubation conditions		5 Minutes	No