Clinical trial NCT05000814: Study of Cost-effectiveness of the Airway Management in Thoracic Surgery
Official title: Study of Cost-effectiveness of the Airway Management and Pulmonary Isolation in Thoracic Surgery Using Standard Double Lumen Tubes vs VivaSight-DL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brief Description of Focus of Study Instead
Lead sponsor: Hospital General Valencia
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing lung resection by thoracotomy, VATS or robotic thoracic surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VDLT reduces the use of fiberoptic bronchoscope
timeFrame: 4 years
measure: Costs associated with the use of VDLT
timeFrame: 4 years
measure: Costs associated with the use of cDLT and fiberoptic bronchoscope
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ruth Martinez Plumed
Study officials:
name: Ruth Martinez Plumed
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Spanish Society of Anesthesia and Critical Care
name: Manuel Granell Gil
role: PRINCIPAL_INVESTIGATOR
References: