Double-lumen Tubes (DLT) - Health Economic Study

Not Applicable

Completed

• Conditions: Single Lung Ventilation; Anesthesia; Thoracic Surgery; Cost-effectiveness
• Interventions: Procedure: VivaSight double-lumen tube for single-lung ventilation; Procedure: Conventional double-lument tube for single-lung ventilation

• Registration Number: NCT03817879
• Lead Sponsor: Ambu A/S

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.

Study Timeline

• Study Start: 2018-11-02
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-28
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-10
• Results First Submitted: 2019-10-14
• Results First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Results First Posted: 2020-02-13
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VivaSight double-lumen tube	VivaSight double-lumen tube for single-lung ventilation	-
Conventional double-lumen tube	Conventional double-lument tube for single-lung ventilation	-

Primary Outcome Measures

Name	Time	Method
Number of Times Bronchoscope is Used	During procedure, up to 4 hours

Secondary Outcome Measures

Name	Time	Method
Intubation Time	During procedure, up to 4 hours
Number of Time the Tube Was Repositioned	During procedure, up to 4 hours
Number of Times Repositioning of the Tube Was Prevented	During procedure, up to 4 hours
Number of Intubation Attempts	During procedure, up to 4 hours
Cost Per Procedure	An average of 1 year

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark