Status:
COMPLETED
Double-lumen Tubes (DLT) - Health Economic Study
Lead Sponsor:
Ambu A/S
Conditions:
Single Lung Ventilation
Thoracic Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during tho...
Detailed Description
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects ...
Eligibility Criteria
Inclusion
- Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
- The subject or legal representative has signed the Informed Consent
- The subject is admitted at Odense University Hospital (OUH), department V
- Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
- Subjects \> 18 years of age
Exclusion
- Subjects with known tracheobronchial anatomic anomalies
- Subjects going for emergency procedures
- Subjects with anticipated difficult airways
- Subjects with known tracheal pathology
- Subjects requiring rapid sequence induction
- Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers)
- Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT)
- Subjects requiring a right-sided DLT
- Subjects who had participated in the study before
Key Trial Info
Start Date :
November 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03817879
Start Date
November 2 2018
End Date
January 31 2019
Last Update
February 13 2020
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000