AirGo™ Respiratory Monitoring in Lung Resection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • AirGoTM system

    Device

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: AirGo Respiratory MonitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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