NCT03368612

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2019

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

November 14, 2017

Last Update Submit

December 5, 2017

Conditions

Respiration Disorders

Outcome Measures

Primary Outcomes (1)

  • respiratory rate

    number of respiratory cycles completed in one minute

    4 minutes

Secondary Outcomes (1)

  • tidal volume

    4 minutes

Interventions

Electronic evaluation systemOTHER

spirometry, plethysmography, cardiopulmonary exercise test

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O. S. Croce E Carle Di Cuneo

Cuneo, 12100, Italy

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

ANDREA ANTONELLI, MD

CONTACT

+39017161ANTONELLI.A@OSPEDALE.CUNEO.IT

ALESSIA STANZI, MD

CONTACT

+39017161STANZI.A@OSPEDALE.CUNEO.IT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

November 14, 2017

First Posted

December 11, 2017

Study Start

September 22, 2017

Primary Completion

September 22, 2019

Study Completion

September 22, 2019

Last Updated

December 11, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)