Prospective randomised cross over comparison on the physiological response to non-invasive ventilation using either Air O2 or Heliox21 - Physiological response to Heliox21 and Air O2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009599-11-GB

Enrollment

Registered

2010-12-30

Start date

2011-02-15

Completion date

Unknown

Last updated

2014-06-30

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

Conditions

Respiratory failure

Interventions

Trade Name: Heliox21 Product Name: Heliox21 Product Code: V03AN03 Pharmaceutical Form: Inhalation gas INN or Proposed INN: Helium CAS Number: 7440597 Concentration unit: % (V/V) percent volume/volume

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged =18 years 2. Males 3. Females 4. Any patient requiring mechanical ventilation for 5 days or more and/or has a tracheostomy to assist weaning from mechanical ventilation who has one or more of following risk factors suggesting that they are at risk of needing post extubation continuous positive airway pressure continuous positive airway pressure (CPAP), BiLevel positive airway pressure (BiPAP) or non-invasive ventilation (NIV): a. BMI of 28 or more b. Underlying respiratory disease (including asthma, COPD and bronchiectasis) as documented in medical notes for this current hospital admission. c. SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Age < 18 years 2. Patient/ Personal Legal Representative refusal or inability to consent 3. Adults with learning disabilities/ dementia 4. Any contraindication to non-invasive ventilation: - Inability to use mask (trauma/surgery) - Excessive secretions - Haemodynamic instability/life threatening arrhythmia 5. High risk of aspiration: - Impaired mental status (Detained under the Mental Health Act) - Un-co-operative/ agitated patient - Life threatening refractory hypoxemia - Undrained pneumothorax - Bullae on X-Ray - Recent upper GI anastamosis 6. Patients already enrolled in an interventional study 7. Females known to be pregnant

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. To estimate the difference between the physiological response on Air O2 and the response on Heliox21 in the immediate stage post extubation of the Intensive Care patients.;Secondary Objective: NA;Primary end point(s): The primary outcome of this study is the measurement of breathing rate to tidal volume (f/VT) ratio as described by Yang and Tobin during trials of weaning patients from mechanical ventilation. The authors concluded that rapid shallow breathing, as reflected by a high f/VT ratio, was the most accurate predictor of failure, and its absence the most accurate predictor of success in weaning patients form mechanical ventilation. An f/VT ratio of over 105 predicted failure of extubation and high likelihood of the need for re-intubation. We will therefore measure and compare the f/VT ratio (respiratory rate / tidal volume) after the 4th and 8th hour of medical gas administration during the study.	—

Measure

Time frame

Main Objective: This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. To estimate the difference between the physiological response on Air O2 and the response on Heliox21 in the immediate stage post extubation of the Intensive Care patients.;Secondary Objective: NA;Primary end point(s): The primary outcome of this study is the measurement of breathing rate to tidal volume (f/VT) ratio as described by Yang and Tobin during trials of weaning patients from mechanical ventilation. The authors concluded that rapid shallow breathing, as reflected by a high f/VT ratio, was the most accurate predictor of failure, and its absence the most accurate predictor of success in weaning patients form mechanical ventilation. An f/VT ratio of over 105 predicted failure of extubation and high likelihood of the need for re-intubation. We will therefore measure and compare the f/VT ratio (respiratory rate / tidal volume) after the 4th and 8th hour of medical gas administration during the study.

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Countries

United Kingdom

Outcome results

None listed

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