Study of Cost-effectiveness of the Airway Management in Thoracic Surgery

Study of Cost-effectiveness of the Airway Management and Pulmonary Isolation in Thoracic Surgery Using Standard Double Lumen Tubes vs VivaSight-DL

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.

Study Overview

• Status: Recruiting
• Conditions: Brief Description of Focus of Study Instead
• Intervention / Treatment: Device: DLT

Detailed Description

The investigators want to carry out a comparative clinical study on the use of conventional double-lumen endobronchial tubes (cDLT) or video double-lumen endobronquial tubes Vivasight DL (VDLT) during intubation in thoracic lung resection surgery, to study their possible advantages and disadvantages.

This will be a prospective, single-center cohort study of Thoracic Surgery in which the VivaSight-DL (n = 55 patients) or conventional DLT (n = 55 patients) is used for lung isolation in elderly patients (≥ 18 years), thoracic surgery procedures of the "lung resection" type: wedge resection, transegmental resection, lobectomy, bilobectomy or pneumectomy by the different surgical approaches: VATS, robotic surgery and thoracotomy.

The objective of this study is to find out if the use of VDLT reduces the need for fiberoptic bronchoscope (FBS) to verify the positioning of the endobronchial tube during intubation and intraoperatively. Reducing the need for FBS could improve the quality of care provided to the patient and reduce costs to the hospital.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Ruth Martinez Plumed, Medicine; Phone Number: 34652678215; Email: ruth.martinez.plumed@gmail.com
• Study Contact Backup: Name: Manuel Granell Gil, Medicine; Phone Number: 34609232031; Email: mgranellg@hotmail.com

Study Locations

• Spain
  • Valencia, Spain, 46007
    • Recruiting
    • Ruth Martinez Plumed
    • Contact: RUTH MARTINEZ PLUMED; Phone Number: 652678215; Email: RUTH.MARTINEZ.PLUMED@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cDLT; patients using conventional double lumen tube for thoracic surgery	Device: DLT; VDLT versus the use of DLT with fiberoptic bronchoscope
VDLT; patients using Vivasight DLT for thoracic surgery	Device: DLT; VDLT versus the use of DLT with fiberoptic bronchoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital General Valencia
• Investigators: Principal Investigator: Ruth Martinez Plumed; Principal Investigator: Manuel Granell Gil, Professor, Spanish Society of Anesthesia and Critical Care

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

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