Respiratory MonitoringNCT07838025
AirGo™ Respiratory Monitoring in Lung Resection
A study testing AirGoTM system in people with Respiratory Monitoring and Thoracic Surgery, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Respiratory Monitoring, Thoracic Surgery, Lung Resection Surgery
- What is being tested?
- AirGoTM system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2026to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Arianna Farronato, MD, 0382-503521 ext. 0382503515, a.farronato@smatteo.pv.it
About this study
Official title: Perioperative Real-time Respiratory Assessment in Lung Resections With a New Device: the AirGoTM System
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.
- Conditions
- Respiratory Monitoring, Thoracic Surgery, Lung Resection Surgery, Respiratory Function, Perioperative Monitoring
- Being tested
- AirGoTM system
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirGoTM systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AirGo Respiratory Monitoring | Experimental | 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. Receives: Device: AirGoTM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From preoperative baseline to the first postoperative day
Secondary outcomes (5)
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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: From device application through 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start7 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arianna Farronato, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838025
- Sponsor's protocol ID
- AirGoLR
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No