Clinical trial NCT03817879: Double-lumen Tubes (DLT) - Health Economic Study
Official title: A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Lung Ventilation
Thoracic Surgery
Anesthesia
Cost-effectiveness
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.

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 will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.

The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Times Bronchoscope is Used
timeFrame: During procedure, up to 4 hours
Secondary outcomes:
measure: Intubation Time
timeFrame: During procedure, up to 4 hours
measure: Number of Intubation Attempts
timeFrame: During procedure, up to 4 hours
measure: Number of Time the Tube Was Repositioned
timeFrame: During procedure, up to 4 hours
measure: Number of Times Repositioning of the Tube Was Prevented
timeFrame: During procedure, up to 4 hours
measure: Cost Per Procedure
timeFrame: An average of 1 year
Other outcomes:
measure: Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.
timeFrame: During procedure, up to 4 hours
measure: Patient Reported Post Operative Outcomes
timeFrame: Within 48 hours after the procedure
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.