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Completed

NCT Number: NCT02088801

Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison.

The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.

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Key information

Conditions

Difficult Intubation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bern University Hospital and University of Bern

Bern, Canton of Bern, 3011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • elective surgery with general anesthesia requiring intubation
  • >18 years old
  • ASA I-III

Exclusion criteria

  • known or presumed difficult airway
  • risk of pulmonary aspiration
  • refusing to participate

Treatment and study plan

Airtraq, blade without channel for tracheal tube intubation

Device

Intubation

Other names: Airtraq, A.P. Advance, KingVision, Macintosh

KingVision , blade without channel for tracheal tube intubation

Device

A.P. Advance, blade without channel for tracheal tube intubation

Device

Macintosh

Device

Primary outcomes

  1. first attempt intubation success rate

    Time frame: intraoperative

Secondary outcomes

  1. side effects

    Time frame: 1h and 1day after intubation

    sore throat, bleeding, dental injuries

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

Acronym: SWIVITII

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2014
Registry last updated
Jun 11, 2015

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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