AirGo™ Respiratory Monitoring in Lung Resection

Fondazione IRCCS Policlinico San Matteo di Pavia20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Respiratory Monitoring

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in Mean Minute Ventilation

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.

Time frame: From preoperative baseline to the first postoperative day

Secondary Outcomes

Change in Mean Minute Ventilation Over Perioperative Timepoints

Change in mean minute ventilation (L/min) measured by the AirGo™ system at preoperative baseline, first postoperative day, second postoperative day, and one month after surgery

Time frame: Preoperative baseline, first postoperative day, second postoperative day, and one month after intervention

Change in Mean Resting Respiratory Rate

Change in mean resting respiratory rate (breaths/min) measured by continuous AirGo™ monitoring at preoperative baseline, first postoperative day, second postoperative day, and one month after surgery.

Time frame: Preoperative baseline, first postoperative day, second postoperative day, and one month after intervention

Patient-Reported Comfort With AirGo™ Monitoring

Patient-reported comfort during AirGo™ monitoring assessed using a standardized Numerical Rating Scale (NRS)

Time frame: During the postoperative period

Agreement Between AirGo™ and Standard Postoperative Monitoring for Respiratory Rate

Agreement between respiratory rate measured by the AirGo™ system and respiratory rate obtained from standard postoperative monitoring, including pulse oximetry and telemetry, during overlapping observation periods.

Time frame: During the postoperative monitoring period on postoperative days 1 and 2

AirGo™ Device-Related Adverse Events

Number of participants experiencing device-related adverse events, including skin irritation, discomfort, interference with surgical wounds, and premature discontinuation of monitoring.

Time frame: From device application through 1 month after intervention