Double-lumen Tubes (DLT) - Health Economic Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Single Lung Ventilation Thoracic Surgery Anesthesia Cost-effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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VivaSight double-lumen tube

Group Type EXPERIMENTAL

VivaSight double-lumen tube for single-lung ventilation

Intervention Type PROCEDURE

Procedure using a tube with a camera

Conventional double-lumen tube

Group Type ACTIVE_COMPARATOR

Conventional double-lument tube for single-lung ventilation

Intervention Type PROCEDURE

Procedure using a tube without a camera

Interventions

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VivaSight double-lumen tube for single-lung ventilation

Procedure using a tube with a camera

Intervention Type PROCEDURE

Conventional double-lument tube for single-lung ventilation

Procedure using a tube without a camera

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No