Obstructive Airways Diseases in Emergency Department (OADED) Study

Terminated

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT02805127
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Study Start: 2016-12-22
• Primary Completion: 2017-08-06
• Study Completion: 2017-08-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between capnography parameters and severity of asthma	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