Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100, Italy
Location status: Recruiting
NCT Number: NCT07838025
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.
Interested in participating?
Request Info21 year–80 year
All sexes
Interventional
Not applicable
Pavia, Lombardy, 27100, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AirGo™ is a non-invasive wireless wearable respiratory monitoring system used for continuous measurement of respiratory parameters, including minute ventilation and respiratory rate, during the perioperative period.
Time frame: 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.
Time frame: Preoperative baseline, first postoperative day, second postoperative day, and one month after intervention
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 (breaths/min) measured by continuous AirGo™ monitoring at preoperative baseline, first postoperative day, second postoperative day, and one month after surgery.
Time frame: During the postoperative period
Patient-reported comfort during AirGo™ monitoring assessed using a standardized Numerical Rating Scale (NRS)
Time frame: During the postoperative monitoring period on postoperative days 1 and 2
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: From device application through 1 month after intervention
Number of participants experiencing device-related adverse events, including skin irritation, discomfort, interference with surgical wounds, and premature discontinuation of monitoring.
Interested in participating?
Request InfoFondazione IRCCS Policlinico San Matteo di Pavia
Other
Perioperative Real-time Respiratory Assessment in Lung Resections With a New Device: the AirGoTM System
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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