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

December 5, 2017 updated by: Andrea Antonelli, Ospedale Santa Croce-Carle Cuneo
The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cuneo, Italy, 12100
        • Recruiting
        • A.O. S. Croce E Carle Di Cuneo
        • Contact:
        • Principal Investigator:
          • ANDREA ANTONELLI, MD
        • Sub-Investigator:
          • ALESSIA STANZI, MD
        • Sub-Investigator:
          • PAOLO NOCETI, MD
        • Sub-Investigator:
          • FEDERICO MAZZA, MD
        • Sub-Investigator:
          • GIULIO MELLONI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory rate
Time Frame: 4 minutes
number of respiratory cycles completed in one minute
4 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2017

Primary Completion (Anticipated)

September 22, 2019

Study Completion (Anticipated)

September 22, 2019

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A.O. S. Croce e Carle di Cuneo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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