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Obstructive Airways Diseases in Emergency Department (OADED) Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805127
Recruitment Status : Terminated (Lower recruitment rate than expected)
First Posted : June 17, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Medtronic - MITG ( Oridion )

Brief Summary:
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

Condition or disease
Asthma Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description:
This is a feasibility observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adults asthma and COPD patients (age >18) that arrive at the Emergency Department (ED). Patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Obstructive Airways Diseases in Emergency Department (OADED) Study
Study Start Date : December 22, 2016
Actual Primary Completion Date : August 6, 2017
Actual Study Completion Date : August 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Patients with COPD and Asthma .

Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken form the subjects with at least two minutes recording before the first spirometry assessment.

All clinical diagnoses and treatments will be performed according to the department's protocols.

This is an observational study with no interventions




Primary Outcome Measures :
  1. Correlation between capnography parameters and severity of asthma [ Time Frame: 1/2 hour to 48 hours from enrollment of subjects ]
    Correlation between the airway obstruction severity calculation based on the capnography parameters and the clinical severity of asthma and COPD as defined by forced expiratory volume in 1 second (FEV1), in severe asthma and COPD patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asthma and COPD patients
Criteria

Inclusion Criteria:

  1. Age >18
  2. Ability and willingness to participate the study and sign informed consent form
  3. Asthma / COPD patients

Exclusion Criteria:

  1. Pregnant women
  2. Asthma or COPD patients with FEV1 > 60%
  3. Disability or unwillingness to undergo capnography measurement
  4. Cannot be assessed for FEV1
  5. Oxygen supply >5 L/min

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): NCT02805127


Sponsors and Collaborators
Oridion
Hadassah Medical Organization
Investigators
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Principal Investigator: Ruth Stalnikowicz, Prof. ; M.D. Emergency Department, Hadassah University Hospital Mount Scopus
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Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT02805127    
Other Study ID Numbers: MDT17071
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic - MITG ( Oridion ):
Asthma
COPD
Capnography
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emergencies
Respiratory Tract Diseases
Lung Diseases
Disease Attributes
Pathologic Processes