Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function

• Conditions: Respiration Disorders

• Registration Number: NCT03368612
• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo

Brief Summary

The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.

Detailed Description

Primary endpoint:

• To test the AirGoTM system's respiratory rate recording accuracy at rest and during physical exercise, as compared to standard tests.

Secondary endpoints:

* To test the accuracy of the AirGoTM system's derived respiratory parameters (tidal volume, minute ventilation, Tiffeneau-Pinelli index, FEV1 and VO2max) at rest and during physical exercise, as compared to standard tests.

* To test comfort and subjects' compliance with the AirGoTM system during long term recording (24 hours).

Study Timeline

• Study Start: 2017-09-22
• Study First Submitted: 2017-11-14
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-05
• Last Update Submitted: 2017-12-05
• Study First Posted: 2017-12-11
• Last Update Posted: 2017-12-11
• Primary Completion: 2019-09-22
• Study Completion: 2019-09-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Non-smoker healthy volunteers,
• Able to perform a routine respiratory function test (spirometry and cardiopulmonary exercise testing),
• aged between 18 and 75 years,
• who signed a written informed consent.

Exclusion Criteria

• Present cardiac comorbidities (eg. coronary artery disease, heart failure, arrhythmias);
• History of coronary artery disease or heart failure;
• Respiratory comorbidities (eg. asthma, chronic obstructive disease, sleep apnoea, lung interstitial disease);
• Pregnancy;
• Former smoker of >5 p/y;
• Severe trauma or major surgery in the last year;
• Chest pain;
• Obesity (BMI >30).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
respiratory rate	4 minutes	number of respiratory cycles completed in one minute

Secondary Outcome Measures

Name	Time	Method
tidal volume	4 minutes	volume of air moved during a single respiratory cycle (inspiration and expiration) during normal breathing (in ml)

Trial Locations

Locations (1)

A.O. S. Croce E Carle Di Cuneo; 🇮🇹 Cuneo, Italy