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

Ospedale Santa Croce-Carle Cuneo

Status: Unknown

Conditions: Respiration Disorders

Treatments: Other: Electronic evaluation system

Study type: Observational

Funder types: Other

Identifiers

NCT03368612

A.O. S. Croce e Carle di Cuneo

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).