Effectiveness of Heliox in Hypercapnic Respiratory Failure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000832-42-GB

Enrollment

Registered

2008-06-27

Start date

2008-11-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Medical Air Product Name: Medical Air Product Code: Medical Air Pharmaceutical Form: Inhalation gas Trade Name: Heliox 21

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: This study is a large randomised controlled study aiming to clarify the efficacy of Heliox in exacerbations of COPD and to establish whether helium/oxygen mixtures in hypercapnic respiratory failure due to exacerbations of COPD leads to more rapid correction of blood carbon dioxide levels compared to air/oxygen mixtures. ; Secondary Objective: 1) To determine whether use of heliox reduces length of stay in COPD exacerbations 2) To determine whether use of heliox in COPD exacerbations reduces the need for non - invasive ventilation ;Primary end point(s): The primary end point of this trial is therefore to assess whether the use of Heliox in patients with hypercapnic respiratory failure, due to a COPD exacerbation, lowers blood carbon dioxide levels more in the initial four hour period than Medical air	—

Measure

Time frame

Main Objective: This study is a large randomised controlled study aiming to clarify the efficacy of Heliox in exacerbations of COPD and to establish whether helium/oxygen mixtures in hypercapnic respiratory failure due to exacerbations of COPD leads to more rapid correction of blood carbon dioxide levels compared to air/oxygen mixtures. ; Secondary Objective: 1) To determine whether use of heliox reduces length of stay in COPD exacerbations 2) To determine whether use of heliox in COPD exacerbations reduces the need for non - invasive ventilation ;Primary end point(s): The primary end point of this trial is therefore to assess whether the use of Heliox in patients with hypercapnic respiratory failure, due to a COPD exacerbation, lowers blood carbon dioxide levels more in the initial four hour period than Medical air

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026