Double-lumen Tubes (DLT) - Health Economic Study

Ambu A/S70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Single Lung Ventilation Thoracic Surgery Anesthesia Cost-effectiveness

Interventions

VivaSight double-lumen tube for single-lung ventilationPROCEDURE

Procedure using a tube with a camera

Conventional double-lument tube for single-lung ventilationPROCEDURE

Procedure using a tube without a camera

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Odense University Hospital

Odense, Denmark