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

Not Applicable

Completed

• Conditions: Intubation; Videolaryngoscopy; Infant
• Interventions: Device: Storz videolaryngoscope; Device: Airtraq

• Registration Number: NCT01090726
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-12-10
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Storz videolaryngoscope	Storz videolaryngoscope	Macintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation.
Airtraq	Airtraq	Macintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation.

Primary Outcome Measures

Name	Time	Method
Success rate	5 minutes	Succes is defined by intubation being executed in the first try.

Secondary Outcome Measures

Name	Time	Method
Time to intubation	5 minutes
Number of intubation attempts	5 Minutes
Time to Cormack evaluation	5 minutes
Quality of laryngeal overview before intubation	5 Minutes	Evaluated by Cormack score
Prevalence of post intubation stridor	12 hours
Intubation conditions	5 Minutes

Trial Locations

Locations (1)

Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark