N/A
N=70
Double-lumen Tubes (DLT) - Health Economic Study
Single Lung Ventilation · Thoracic Surgery · Anesthesia · Cost-effectiveness
Bottom Line
View on ClinicalTrials.gov: NCT03817879 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Number of Times Bronchoscope is Used — 0.07; 3.14 Reported uses of bronchoscopes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VivaSight double-lumen tube for single-lung ventilation (Procedure); Conventional double-lument tube for single-lung ventilation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ambu A/S
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Times Bronchoscope is Used |
0.07; 3.14 | — |
| SECONDARY Intubation Time |
— | — |
| SECONDARY Number of Intubation Attempts |
— | — |
| SECONDARY Number of Time the Tube Was Repositioned |
— | — |
| SECONDARY Number of Times Repositioning of the Tube Was Prevented |
— | — |
| SECONDARY Cost Per Procedure |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03817879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.