Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064580
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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
Respiratory Pathology Obstructive Syndrome Other: diagnostic test

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : July 2021

Intervention Details:
  • Other: diagnostic test
    performing a capnography examination


Primary Outcome Measures :
  1. Spirometry measurement [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Major patient requiring spirometry breathing functional exploration
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064580


Locations
Layout table for location information
France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04064580    
Other Study ID Numbers: 7245
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
capnography