Perioperative Real-time Respiratory Assessment in Lung Resections With a New Device: the AirGoTM System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Mean Minute Ventilation
研究概览
简要总结
Patients undergoing lung resection surgery may experience changes in respiratory function during the perioperative period. Current monitoring methods provide important clinical information but are often limited to specific time points and may not allow continuous assessment of ventilation. This study aims to evaluate the feasibility and usefulness of the AirGo™ wearable respiratory monitoring system in patients undergoing anatomical lung resection (lobectomy or segmentectomy). AirGo™ is a non-invasive, CE-marked device that continuously measures respiratory parameters, including minute ventilation and respiratory rate, through a chest-worn sensor. Participants will wear the AirGo™ device before surgery and during the postoperative period. Respiratory parameters collected by AirGo™ will be analyzed at predefined time points and compared with standard clinical monitoring methods routinely used in postoperative care, including pulse oximetry and telemetry. The primary objective is to assess changes in mean minute ventilation from the preoperative period to the first postoperative day. Secondary objectives include evaluating perioperative respiratory trends, patient comfort and compliance with the device, and the agreement between AirGo™ measurements and standard monitoring systems. The results of this study may help determine whether continuous non-invasive respiratory monitoring can improve the assessment and management of patients undergoing lung surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for minimally invasive anatomical lung resection, specifically Video-Assisted thoracic surgery (VATS) lobectomy or segmentectomy, performed for diagnostic or curative purposes;
- •Patients capable of performing a spirometry
- •Age between 21 and 80 years
- •Patient consented to the study by signing the consent
排除标准
- •Pre-operative presence of pneumothorax and/or pleural effusion
- •Pregnancy
- •Severe trauma or major surgery in the last year previous cardio-thoracic surgery (including spinal surgery)
- •Preoperative chest pain or low back pain,
- •Obesity (BMI >30)
- •Emergency surgery
- •Patients scheduled for anatomical lung resection
- •Specifically thoracotomy lobectomy or segmentectomy
- •Scheduled bi-lobectomy or pneumonectomy or extended sleeve lobectomy
- •Lung resection extended to the chest wall
- •Inability to follow procedures
- •Insufficient knowledge of project language (italian)
- •Inability to give consent
研究组 & 干预措施
AirGo Respiratory Monitoring
Participants undergoing minimally invasive anatomical lung resection (VATS, lobectomy or segmentectomy) will undergo perioperative respiratory monitoring using the AirGo™ device in addition to standard clinical care. Respiratory parameters, including minute ventilation and respiratory rate, will be assessed at predefined timepoints before and after surgery.
干预措施: AirGoTM system (Device)
结局指标
主要结局
Change in Mean Minute Ventilation
时间窗: From preoperative baseline to the first postoperative day
Difference in mean minute ventilation (L/min), measured by the AirGo™ system during a 60-minute resting recording, between the preoperative assessment and the first postoperative day.
次要结局
- Change in Mean Minute Ventilation Over Perioperative Timepoints(Preoperative baseline, first postoperative day, second postoperative day, and one month after intervention)
- Change in Mean Resting Respiratory Rate(Preoperative baseline, first postoperative day, second postoperative day, and one month after intervention)
- Patient-Reported Comfort With AirGo™ Monitoring(During the postoperative period)
- Agreement Between AirGo™ and Standard Postoperative Monitoring for Respiratory Rate(During the postoperative monitoring period on postoperative days 1 and 2)
- AirGo™ Device-Related Adverse Events(From device application through 1 month after intervention)
研究者
Arianna Farronato
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia