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

Brief Description of Focus of Study Instead Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000814
• Other study ID #: 2021
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: November 2023
• Source: Hospital General Valencia
• Contact: Ruth Martinez Plumed, Medicine
• Phone: 34652678215
• Email: ruth.martinez.plumed[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 1, 2026
• Est. primary completion date: December 1, 2025
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brief Description of Focus of Study Instead

Intervention

Device:
• DLT
VDLT versus the use of DLT with fiberoptic bronchoscope

Locations

Country	Name	City	State
Spain	Ruth Martinez Plumed	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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