Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05000814
Enrollment
110
Registered
2021-08-11
Start date
2023-11-30
Completion date
2026-02-01
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brief Description of Focus of Study Instead

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.

Interventions

DEVICEDLT

VDLT versus the use of DLT with fiberoptic bronchoscope

Sponsors

Hospital General Valencia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
VDLT reduces the use of fiberoptic bronchoscope4 yearsDetermine 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 VDLT4 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 bronchoscope4 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.

Countries

Spain

Contacts

Primary ContactRuth Martinez Plumed, Medicine
ruth.martinez.plumed@gmail.com34652678215
Backup ContactManuel Granell Gil, Medicine
mgranellg@hotmail.com34609232031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026