Obstructive Airways Diseases in Emergency Department (OADED) Study

Asthma Clinical Trial

Official title:

Obstructive Airways Diseases in Emergency Department (OADED) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02805127
• Other study ID #: MDT17071
• Status: Terminated
• Phase: N/A
• First received: June 15, 2016
• Last updated: December 6, 2017
• Start date: December 22, 2016
• Est. completion date: August 6, 2017

Study information

• Verified date: December 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 6, 2017
• Est. primary completion date: August 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)
• Emergencies
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oridion	Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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