Respiration DisordersAirGoTMNCT03368612
Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function
An observational study of Respiration Disorders, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
Trial summary
The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiration Disorders
- What is being tested?
- Electronic evaluation system
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2017to 22 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
A.O. S. Croce E Carle Di Cuneo
Cuneo, 12100
FRANCESCO GIURLANDA, +39017161 ext. 6790, TRIALS@OSPEDALE.CUNEO.IT
ANDREA ANTONELLI, MD
About this study
The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.
Read the 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).
- Conditions
- Respiration Disorders
- Being tested
- Electronic evaluation system
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic evaluation systemOther
spirometry, plethysmography, cardiopulmonary exercise test
Electronic evaluation systemOther
Also called AirGoTM System
AirGo recording
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory rate
number of respiratory cycles completed in one minute
Measured: 4 minutes
Secondary outcomes (1)
tidal volume
volume of air moved during a single respiratory cycle (inspiration and expiration) during normal breathing (in ml)
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start22 Sep 2017
- Primary completion22 Sep 2019 (estimated)
- Study completion22 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Antonelli, Ospedale Santa Croce-Carle Cuneo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368612
- Sponsor's protocol ID
- A.O. S. Croce e Carle di Cuneo
- Acronym
- AirGoTM
- Status last verified
- Dec 2017
- First submitted
- 14 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function
- ClinicalTrials.gov ID
- NCT03368612
- Acronym / sponsor ID
- AirGoTM / A.O. S. Croce e Carle di Cuneo
- Conditions
- Respiration Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 22 Sep 2019 (estimated)
- Study completion
- 22 Sep 2019 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic evaluation systemspirometry, plethysmography, cardiopulmonary exercise test | Other | – |
| Electronic evaluation systemAlso: AirGoTM SystemAirGo recording | Other | – |
Primary outcome
respiratory rate
Time frame: 4 minutes
number of respiratory cycles completed in one minute
1 secondary outcome
tidal volume
Time frame: 4 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration Disorders, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANDREA ANTONELLI, MD (+39017161 ext. 6794, ANTONELLI.A@OSPEDALE.CUNEO.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory rate (time frame: 4 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.