NCT05000814

Brief Summary

The investigators want to carry out a study to determine the role of Doble Lumen Tubes with built-in camera Viva Sight-DL (VDLT) in thoracic surgery. With this study the investigators want to study and enlarge the information in the different surgical approaches, including robotic surgery. The objective of this study is report a single-center experience using individual data costs to compare the cost effectiveness of VDLT Viva Sight versus the use of conventional Doble Lumen Tubes (cDLT) together with fiberoptic bronchoscope in patients undergoing thoracic surgery, in order to generate information for future decision making related to both devices.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 13, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
2.3 years until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

April 13, 2021

Last Update Submit

November 16, 2023

Conditions

Brief Description of Focus of Study Instead

Outcome Measures

Primary Outcomes (3)

  • VDLT reduces the use of fiberoptic bronchoscope

    Determine if the use of VivaSight-DL® for lung isolation during lung resections is associated with less need for the use of fiberoptic bronchoscope to check the patient's airway during Thoracic Surgery compared to a conventional double-lumen tube.The cases where VDLT is used and the fiberoptic bronchoscope is necessary will be quantified.

    4 years

  • Costs associated with the use of VDLT

    * Cost of airway material: includes the use of cDLT as well as the use or not of fiberoptic bronchoscope. The costs of maintenance and cleaning of the same will be included. * Cost of the surgical intervention taking the cost / minute of thoracic surgery. Surgeon and surgical assistant, an anesthesiologist, three nurses, a clinic assistant and a caretaker work in these operating rooms. These last two professionals are shared with other operating rooms in the surgical area. * Cost of stays in hospitalization room / ICU.

    4 years

  • Costs associated with the use of cDLT and fiberoptic bronchoscope

    * Cost of airway material: includes the use of cDLT as well as the use or not of fiberoptic bronchoscope. The costs of maintenance and cleaning of the same will be included. * Cost of the surgical intervention taking the cost / minute of thoracic surgery. Surgeon and surgical assistant, an anesthesiologist, three nurses, a clinic assistant and a caretaker work in these operating rooms. These last two professionals are shared with other operating rooms in the surgical area. * Cost of stays in hospitalization room / ICU.

    4 years

Study Arms (2)

cDLT

patients using conventional double lumen tube for thoracic surgery

Device: DLT

VDLT

patients using Vivasight DLT for thoracic surgery

Device: DLT

Interventions

DLTDEVICE

VDLT versus the use of DLT with fiberoptic bronchoscope

VDLTcDLT

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing lung resection by thoracotomy, VATS or robotic thoracic surgery.

You may qualify if:

  • Patients of legal age (≥18 years).
  • Patients who require one-lung collapse in Thoracic Surgery procedures.

You may not qualify if:

  • Patients with predicted difficult airway.
  • Left main bronchus anomalies.
  • Previous thoracic surgery.
  • BMI\> 40.
  • Patients with tracheostomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruth Martinez Plumed

Valencia, 46007, Spain

RECRUITING

Study Officials

  • Ruth Martinez Plumed

    PRINCIPAL INVESTIGATOR

  • Manuel Granell Gil

    Professor, Spanish Society of Anesthesia and Critical Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Martinez Plumed, Medicine

CONTACT

34652678215ruth.martinez.plumed@gmail.com

Manuel Granell Gil, Medicine

CONTACT

34609232031mgranellg@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2021

First Posted

August 11, 2021

Study Start

November 30, 2023

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

ES(1)