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

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 )

Tracking Information
First Submitted Date June 15, 2016
First Posted Date June 17, 2016
Last Update Posted Date December 8, 2017
Study Start Date December 22, 2016
Actual Primary Completion Date August 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obstructive Airways Diseases in Emergency Department (OADED) Study
Official Title Obstructive Airways Diseases in Emergency Department (OADED) Study
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Asthma and COPD patients
Condition
  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
Intervention Not Provided
Study Groups/Cohorts 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

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: December 6, 2017)
12
Original Estimated Enrollment
 (submitted: June 16, 2016)
30
Actual Study Completion Date August 6, 2017
Actual Primary Completion Date August 6, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02805127
Other Study ID Numbers MDT17071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medtronic - MITG ( Oridion )
Study Sponsor Oridion
Collaborators Hadassah Medical Organization
Investigators
Principal Investigator: Ruth Stalnikowicz, Prof. ; M.D. Emergency Department, Hadassah University Hospital Mount Scopus
PRS Account Medtronic - MITG
Verification Date December 2017