Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

Difficult Intubation Clinical Trial

— SWIVITII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088801
• Other study ID #: 106/12_2
• Secondary ID: SWIVIT II
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: June 10, 2015
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkomission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• Airtraq, blade without channel for tracheal tube intubation
Intubation
• KingVision , blade without channel for tracheal tube intubation

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

• Macintosh

Locations

Country	Name	City	State
Switzerland	Bern University Hospital and University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first attempt intubation success rate		intraoperative	No
Secondary	side effects	sore throat, bleeding, dental injuries	1h and 1day after intubation	Yes