Double-lumen Tubes (DLT) - Health Economic Study

A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VivaSight double-lumen tube	Procedure: VivaSight double-lumen tube for single-lung ventilation; Procedure using a tube with a camera
Active Comparator: Conventional double-lumen tube	Procedure: Conventional double-lument tube for single-lung ventilation; Procedure using a tube without a camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Times Bronchoscope is Used	During procedure, up to 4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Intubation Time	During procedure, up to 4 hours
Number of Intubation Attempts	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
Cost Per Procedure	An average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.	Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)	During procedure, up to 4 hours
Patient Reported Post Operative Outcomes	Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)	Within 48 hours after the procedure

Collaborators and Investigators

• Sponsor: Ambu A/S

Publications and helpful links

General Publications

• Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CIS-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will described in groups

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No