Obstructive Airways Diseases in Emergency Department (OADED) Study

NCT02805127 | Terminated

• 1 other identifier: MDT17071
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Asthma; COPD; Capnography

Outcome Measures

Primary Outcomes (1)

• Correlation between capnography parameters and severity of asthma

  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

  1/2 hour to 48 hours from enrollment of subjects

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthma and COPD patients

You may qualify if:

• Age \>18
• Ability and willingness to participate the study and sign informed consent form
• Asthma / COPD patients

You may not qualify if:

• Pregnant women
• Asthma or COPD patients with FEV1 \> 60%
• Disability or unwillingness to undergo capnography measurement
• Cannot be assessed for FEV1
• Oxygen supply \>5 L/min

Sponsors & Collaborators

• Oridion: lead
• Hadassah Medical Organization: collaborator

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruth Stalnikowicz, Prof. ; M.D.

  Emergency Department, Hadassah University Hospital Mount Scopus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: December 22, 2016
• Primary Completion: August 6, 2017
• Study Completion: August 6, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share