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

NCT ID: NCT01090726

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Intubation Videolaryngoscopy Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Storz videolaryngoscope

Macintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation.

Group Type EXPERIMENTAL

Storz videolaryngoscope

Intervention Type DEVICE

Storz videolaryngoscope being used for the actual intubation

Airtraq

Macintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation.

Group Type ACTIVE_COMPARATOR

Airtraq

Intervention Type DEVICE

Airtraq being used for the actual intubation

Interventions

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Storz videolaryngoscope

Storz videolaryngoscope being used for the actual intubation

Intervention Type DEVICE

Airtraq

Airtraq being used for the actual intubation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Locations

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Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 37171122 (View on PubMed)

Sorensen 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.

Reference Type DERIVED
PMID: 22545575 (View on PubMed)

Other Identifiers

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1A-INF-STORZ-AIR

Identifier Type: -

Identifier Source: org_study_id