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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Pathology; Obstructive Syndrome
• Intervention / Treatment: Other: diagnostic test

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Major patient requiring spirometry breathing functional exploration

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: capnography
• Other Study ID Numbers: 7245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No