Double-lumen Tubes (DLT) - Health Economic Study

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817879
• Other study ID #: CIS-009
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: October 2019
• Source: Ambu A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cost-effectiveness
• Single Lung Ventilation
• Thoracic Surgery

Intervention

Procedure:
• VivaSight double-lumen tube for single-lung ventilation
Procedure using a tube with a camera
• Conventional double-lument tube for single-lung ventilation
Procedure using a tube without a camera

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Ambu A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. 2019 Jul 11. doi: 10.1007/s41669-019-0163-y. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Number of Times Bronchoscope is Used		During procedure, up to 4 hours
Secondary	Intubation Time		During procedure, up to 4 hours
Secondary	Number of Intubation Attempts		During procedure, up to 4 hours
Secondary	Number of Time the Tube Was Repositioned		During procedure, up to 4 hours
Secondary	Number of Times Repositioning of the Tube Was Prevented		During procedure, up to 4 hours
Secondary	Cost Per Procedure		An average of 1 year