Obstructive Syndrome Clinical Trial
— CAPNOBSTOfficial title:
Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve
NCT number | NCT04064580 |
Other study ID # | 7245 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 2019 |
Est. completion date | July 2021 |
Verified date | July 2019 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Obstructive respiratory diseases such as asthma or COPD are a common reason for emergency
room visits. Currently, nasal gill capnography and oxygen saturation measurement (SpO2) are
the only two non-invasive means of continuously monitoring a respiratory pathology. To date,
Respiratory Functional Explorations (CFE) and more particularly spirometry, are considered as
the reference examinations for the diagnosis or monitoring of asthma or COPD. However,
physical and physical constraints make their use almost impossible in the context of the
emergency with patients presenting to emergencies in respiratory distress, often require
oxygen therapy or even non-invasive ventilation. Only pulmonary auscultation can make the
diagnosis of acute decompensation of obstructive pathology. This technique is qualitative and
imprecise, sometimes leading to a diagnostic uncertainty resulting in delay in taking charge
and inappropriate therapy.
Studies have shown a change in the capnography curve in obstructive airway disorder and a
strong correlation between some capnography parameters and spirometry parameters such as the
Tiffeneau ratio (FEV1 / FVC), suggesting capnography as a simple and effective technique for
the diagnosis of obstructive syndrome of patients in emergencies.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | July 2021 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Major patient male or female - Patient with respiratory disease with and without obstructive syndrome or patient without respiratory pathology - Patient requiring spirometry breathing functional exploration - Subject affiliated to a social health insurance scheme - Subject able to understand the objectives and the risks related to the research and to give its non opposition Exclusion Criteria: - Pregnant and lactating woman - Patient not affiliated to a social protection scheme - Subject in exclusion period (determined by previous or current study), - Impossibility of giving the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...) - Subject under the protection of justice Subject under guardianship or curatorship |
Country | Name | City | State |
---|---|---|---|
France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spirometry measurement | Tiffenau Report Compendium (FEV1 / FVC) and FEV1 for spirometry (gold standard defining presence of obstructive disorder). Collection of the capnography curves of each patient allowing in a second time to perform an analysis of the curve by different methods. |
1 day |