Effectiveness of Heliox in Hypercapnic Respiratory Failure

Phase 1

• Conditions: Hypercapnic Respiratory Failure due to excerbation of Chronic Obstructive Pulmonary Disease; MedDRA version: 9.1 Level: LLT Classification code 10010953 Term: COPD exacerbation

• Registration Number: EUCTR2008-000832-42-GB
• Lead Sponsor: East Kent Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-27
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1. All patients with hypercapnic respiratory failure due to exacerbations of COPD admitted to A&E/ CDU at the William Harvey Hospital will be considered for the study.
Patients therefore need to be

1)Acidotic ( arterial blood gas pH < 7.35) due to high blood carbon dioxide
levels
2)Have a formal diagnosis of COPD
3)Be admitted with an exacerbation of COPD
4) PO2 < 8kpa
5) PCO2 > 7kpa

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

1) Patients deemed not competent to make a decision about consent for the study by the admitting doctor based on Abbreviated Mental Test Score < 7 out of 10

2) Patients who are comatose / drowsy on admission and unable to communicate

3) Patients requiring immediate NIV or Intubation at time of assessment by member of research team / Medical Registrar. ( In some situations patients may have had delay in assessment by A&E staff or have received controlled oxygen therapy by paramedics . If these patients are deteriorating when assessed they will be excluded and started on immediate NIV)

4) Have hypercapnic respiratory failure for a reason other than COPD exacerbation

5) Do not understand verbal/ written information in English

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified