COPD exacerbation - Heliox Therapy - AssessmentHeliox vs. Medical Air in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Pilot Randomised Controlled Trial - Pilot CHeTA

Conditions: Chronic Obstructive Pulmonary Disease
MedDRA version: 9.1Level: LLTClassification code 10010953Term: COPD exacerbation

Registration Number: EUCTR2008-005660-13-GB

Lead Sponsor: BOC Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

• Be admitted to ED with a clinical diagnosis of an acute exacerbation of COPD
(acute onset of a sustained worsening of the patient’s symptoms from their usual
stable state which is beyond normal day-to-day variations).

• Have a Past Medical History of a diagnosis of COPD

• Age > 40 years.

• After initial nebulisation have two of: RR>30, HR>100, purulent
sputum

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Have left ventricular failure.

• Unable to give informed consent.

• Clinical anticipation of intubation or non-invasive ventilation before randomisation.

• Have participated in this trial before.

• Participation in any investigational drug study within 4 weeks preceding or during this study period.

• Clinical suspicion of large consolidation.

• Encephalopathic

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this pilot study is to test the trial protocol and procedures in preparation for a full-scale study, and to estimate the patient recruitment rates at the trial centres.;Secondary Objective: To gather data on the effects of Heliox inhalation during exacerbation of COPD for the purposes of sample size calculation and trial design for a full-scale clinical trial. The trial will collect information about blood gases (CO2, O2), blood pH,dyspnoea,vital signs, oxygenation, and nebulisation before and during treatment with a study gas (Heliox or Medical Air, with additional oxygen as required).;Primary end point(s): To evaluate the feasibility of study procedures and protocol, including the estimation of recruitment rate.

Secondary Outcome Measures