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Completed

NCT Number: NCT01090726

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.

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Key information

Conditions

Intubation Infant Videolaryngoscopy

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Storz videolaryngoscope

Device

Storz videolaryngoscope being used for the actual intubation

Airtraq

Device

Airtraq being used for the actual intubation

Primary outcomes

  1. Success rate

    Time frame: 5 minutes

    Succes is defined by intubation being executed in the first try.

Secondary outcomes

  1. Time to Cormack evaluation

    Time frame: 5 minutes

  2. Time to intubation

    Time frame: 5 minutes

  3. Number of intubation attempts

    Time frame: 5 Minutes

  4. Quality of laryngeal overview before intubation

    Time frame: 5 Minutes

    Evaluated by Cormack score

  5. Prevalence of post intubation stridor

    Time frame: 12 hours

  6. Intubation conditions

    Time frame: 5 Minutes

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2010
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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