Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve

Obstructive Syndrome Clinical Trial

— CAPNOBST  

Official title:

Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04064580
• Other study ID #: 7245
• Status: Not yet recruiting
• Start date: November 2019
• Est. completion date: July 2021

Study information

• Verified date: July 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obstructive Syndrome
• Respiratory Pathology

Intervention

Other:
• diagnostic test
performing a capnography examination

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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