NCT03817879

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 13, 2020

Completed
Last Updated

February 13, 2020

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

January 9, 2019

Results QC Date

October 14, 2019

Last Update Submit

February 3, 2020

Conditions

Single Lung VentilationThoracic SurgeryAnesthesiaCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Number of Times Bronchoscope is Used

    During procedure, up to 4 hours

Secondary Outcomes (5)

  • 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 Outcomes (2)

  • Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.

    During procedure, up to 4 hours

  • Patient Reported Post Operative Outcomes

    Within 48 hours after the procedure

Study Arms (2)

VivaSight double-lumen tube

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

Conventional double-lumen tube

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

Interventions

VivaSight double-lumen tube for single-lung ventilationPROCEDURE

Procedure using a tube with a camera

VivaSight double-lumen tube
Conventional double-lument tube for single-lung ventilationPROCEDURE

Procedure using a tube without a camera

Conventional double-lumen tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related 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. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.

    PMID: 31297752BACKGROUND

MeSH Terms

Interventions

One-Lung Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Results Point of Contact

Title
Anna Charlotte Lundgaard
Organization
Ambu A/S
aclu@ambu.com
+4529643748

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 28, 2019

Study Start

November 2, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

February 13, 2020

Results First Posted

February 13, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Data will described in groups

Locations

DK(1)