- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368612
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: ANDREA ANTONELLI, MD
- Phone Number: 6794 +39017161
- Email: ANTONELLI.A@OSPEDALE.CUNEO.IT
Study Contact Backup
- Name: ALESSIA STANZI, MD
- Phone Number: 6738 +39017161
- Email: STANZI.A@OSPEDALE.CUNEO.IT
Study Locations
-
-
-
Cuneo, Italy, 12100
- Recruiting
- A.O. S. Croce E Carle Di Cuneo
-
Contact:
- FRANCESCO GIURLANDA
- Phone Number: 6790 +39017161
- Email: TRIALS@OSPEDALE.CUNEO.IT
-
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.
Sponsor
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.
Clinical Trials on Respiration Disorders
-
Imperial College LondonUnknown
-
University of Milano BicoccaCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Kaohsiung Veterans General Hospital.CompletedRespiratory Failure | Respiration, ArtificialTaiwan
-
Unity Health TorontoCompletedRespiratory Insufficiency | Respiration, ArtificialCanada
-
Medical University InnsbruckCompleted
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedRespiratory Insufficiency | PEEP, Intrinsic | PEEP, OccultItaly
-
University of Sao Paulo General HospitalRecruitingRespiratory Insufficiency | Respiration, Artificial | Ventilation Therapy; Complications | Ventilators, MechanicalBrazil
-
University of Sao PauloCompletedElderly Subjects | Respiration ExercisesBrazil
-
ResMedCompletedSubstudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation (MS)Heart Failure | Sleep Disorder | Cheyne Stokes RespirationAustralia, Germany, Switzerland, Netherlands, France, Finland, Czech Republic, United Kingdom
Clinical Trials on Electronic evaluation system
-
Mayo ClinicCenters for Medicare and Medicaid ServicesCompletedSepsis | Shock | Critical Illness | Respiratory Failure | Bleeding | Trauma | ComaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Breast Carcinoma | Head and Neck Carcinoma | Lung CarcinomaUnited States
-
OHSU Knight Cancer InstituteRecruitingHead and Neck CarcinomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science UniversityRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Xoft, Inc.CompletedEndometrial CancerUnited States
-
University of AarhusCompleted
-
Brigham and Women's HospitalThe Commonwealth FundCompletedCommunication | Interprofessional RelationsUnited States
-
Manchester University NHS Foundation TrustCardiff University; University of Manchester; National Institute for Health Research... and other collaboratorsCompletedModerate or Severe Vision Impairment, Both EyesUnited Kingdom
-
Xoft, Inc.Icad, Inc.CompletedCervical CancerUnited States