AirGo™ Respiratory Monitoring in Lung Resection

NCT07838025 | Recruiting

• 1 other identifier: AirGoLR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

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.

  From preoperative baseline to the first postoperative day

Secondary Outcomes (5)

• Change in Mean Minute Ventilation Over Perioperative Timepoints

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

• Change in Mean Resting Respiratory Rate

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

• Patient-Reported Comfort With AirGo™ Monitoring

  During the postoperative period

• Agreement Between AirGo™ and Standard Postoperative Monitoring for Respiratory Rate

  During the postoperative monitoring period on postoperative days 1 and 2

• AirGo™ Device-Related Adverse Events

  From device application through 1 month after intervention

Study Arms (1)

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.

Device: AirGoTM system

Interventions

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.

AirGo Respiratory Monitoring

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 24, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

IT (1)