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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03368612

Acronym

AirGoTM

Enrollment

100

Registered

2017-12-11

Start date

2017-09-22

Completion date

2019-09-22

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Disorders

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).

Interventions

OTHERElectronic evaluation system

spirometry, plethysmography, cardiopulmonary exercise test

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
respiratory rate	4 minutes	number of respiratory cycles completed in one minute

Secondary

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

Countries

Italy

Contacts

Primary ContactANDREA ANTONELLI, MD

ANTONELLI.A@OSPEDALE.CUNEO.IT+39017161

Backup ContactALESSIA STANZI, MD

STANZI.A@OSPEDALE.CUNEO.IT+39017161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026