Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 13, 2010
March 1, 2010
7 months
March 18, 2010
December 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate
Succes is defined by intubation being executed in the first try.
5 minutes
Secondary Outcomes (6)
Time to Cormack evaluation
5 minutes
Time to intubation
5 minutes
Number of intubation attempts
5 Minutes
Quality of laryngeal overview before intubation
5 Minutes
Prevalence of post intubation stridor
12 hours
- +1 more secondary outcomes
Study Arms (2)
Storz videolaryngoscope
EXPERIMENTALMacintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation.
Airtraq
ACTIVE COMPARATORMacintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation.
Interventions
Storz videolaryngoscope being used for the actual intubation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Expected difficult airway.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (2)
Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.
PMID: 37171122DERIVEDSorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
PMID: 22545575DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 22, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 13, 2010
Record last verified: 2010-03