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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT04064580
Collaborator
(none)
300
1
20
15

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: diagnostic test

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Jul 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Spirometry measurement [1 day]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Les Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT04064580
Other Study ID Numbers:
  • 7245
First Posted:
Aug 22, 2019
Last Update Posted:
Oct 15, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Strasbourg, France

Study Results

No Results Posted as of Oct 15, 2019