Double-lumen Tubes (DLT) - Health Economic Study

Ambu

Status

Completed

Conditions

Single Lung Ventilation

Cost-effectiveness

Anesthesia

Thoracic Surgery

Treatments

Procedure: VivaSight double-lumen tube for single-lung ventilation

Procedure: Conventional double-lument tube for single-lung ventilation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03817879

CIS-009

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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