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NCT Number: NCT07838025

AirGo™ Respiratory Monitoring in Lung Resection

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Mean Minute Ventilation

    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.

Secondary outcomes

  1. Change in Mean Minute Ventilation Over Perioperative Timepoints

    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

  2. Change in Mean Resting Respiratory Rate

    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.

  3. Patient-Reported Comfort With AirGo™ Monitoring

    Time frame: During the postoperative period

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

  4. Agreement Between AirGo™ and Standard Postoperative Monitoring for Respiratory Rate

    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.

  5. AirGo™ Device-Related Adverse Events

    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?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Perioperative Real-time Respiratory Assessment in Lung Resections With a New Device: the AirGoTM System

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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