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

Recruiting

• Conditions: Brief Description of Focus of Study Instead
• Interventions: Device: DLT

• Registration Number: NCT05000814
• Lead Sponsor: Hospital General Valencia

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.

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 Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-08-08
• Study First Posted: 2021-08-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Study Start: 2023-11-30
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VDLT	DLT	patients using Vivasight DLT for thoracic surgery
cDLT	DLT	patients using conventional double lumen tube for thoracic surgery

Primary Outcome Measures

Name	Time	Method
VDLT reduces the use of fiberoptic bronchoscope	4 years	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.
Costs associated with the use of VDLT	4 years	* 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.
Costs associated with the use of cDLT and fiberoptic bronchoscope	4 years	* 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.

Trial Locations

Locations (1)

Ruth Martinez Plumed; 🇪🇸 Valencia, Spain