跳至主要内容
临床试验/NCT05000814
NCT05000814招募中不适用

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

Hospital General Valencia1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
VDLT reduces the use of fiberoptic bronchoscope

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

VDLT reduces the use of fiberoptic bronchoscope

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hospital General Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruth Martinez Plumed

Principal Investigator

Hospital General Valencia

研究点 (1)

Loading locations...

相似试验

Study of Cost-effectiveness of the Airway Management... | 临床试验