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

Respiration Disorders Clinical Trial

— AirGoTM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03368612
• Other study ID #: A.O. S. Croce e Carle di Cuneo
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: December 5, 2017
• Start date: September 22, 2017
• Est. completion date: September 22, 2019

Study information

• Verified date: December 2017
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: ANDREA ANTONELLI, MD
• Phone: +39017161
• Email: ANTONELLI.A[@]OSPEDALE.CUNEO.IT
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 22, 2019
• Est. primary completion date: September 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Respiration Disorders

Intervention

Other:
• Electronic evaluation system
spirometry, plethysmography, cardiopulmonary exercise test
• Electronic evaluation system
AirGo recording

Locations

Country	Name	City	State
Italy	A.O. S. Croce E Carle Di Cuneo	Cuneo

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Croce-Carle Cuneo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory rate	number of respiratory cycles completed in one minute	4 minutes
Secondary	tidal volume	volume of air moved during a single respiratory cycle (inspiration and expiration) during normal breathing (in ml)	4 minutes