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Completed

NCT Number: NCT03817879

Double-lumen Tubes (DLT) - Health Economic Study

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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Key information

Conditions

Single Lung Ventilation Anesthesia Cost-effectiveness Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VivaSight double-lumen tube for single-lung ventilation

Procedure

Procedure using a tube with a camera

Conventional double-lument tube for single-lung ventilation

Procedure

Procedure using a tube without a camera

Primary outcomes

  1. Number of Times Bronchoscope is Used

    Time frame: During procedure, up to 4 hours

Secondary outcomes

  1. Intubation Time

    Time frame: During procedure, up to 4 hours

  2. Number of Intubation Attempts

    Time frame: During procedure, up to 4 hours

  3. Number of Time the Tube Was Repositioned

    Time frame: During procedure, up to 4 hours

  4. Number of Times Repositioning of the Tube Was Prevented

    Time frame: During procedure, up to 4 hours

  5. Cost Per Procedure

    Time frame: An average of 1 year

Other outcomes

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

    Time frame: During procedure, up to 4 hours

    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)

  2. Patient Reported Post Operative Outcomes

    Time frame: Within 48 hours after the procedure

    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)

Sponsors and collaborators

Lead sponsor

Ambu A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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