Respiratory InsufficiencyPhase 4NCT01498432
Physiological Response to Heliox21 and Air O2
A Phase 4 study testing Heliox21 and Air O2 in people with Respiratory Insufficiency, run by University College, London at 1 site in United Kingdom.
Trial summary
This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas delivery in patients who require non-invasive ventilatory support following extubation on the Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Heliox21 and Air O2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 years
- Males
- Females
- 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 (CPAP), BiLevel positive airway pressure (BiPAP) or non-invasive ventilation (NIV):
- BMI of 28 or more
- Underlying respiratory disease (including asthma, COPD and bronchiectasis) as documented in medical notes for this current hospital admission.
Show all 10Show fewer
- SpO2 < 95% on 35% FiO2 or more
- Smoker
- Ex-smoker less than 12 months
- Ex-smoker 10 pack year* or more history * Pack year = (Number of cigarettes per day X Number of years) ÷ 20
Who cannot join
- Age < 18 years
- Patient/legal representative refusal or inability to consent
- Adults with learning disabilities/ dementia
- Any contraindication to non-invasive ventilation:
- Inability to use mask (trauma/surgery) Excessive secretions Haemodynamic instability/life threatening arrhythmia
- High risk of aspiration:
Show all 14Show fewer
- 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
- Patients already enrolled in an interventional
- Females known to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4, Single Centre, Single Blinded,Prospective Randomised Cross Over Comparison on the Physiological Response of Post Extubation Intensive Care Patients to Non-invasive Ventilation Using Either Air O2 or Heliox21
This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas delivery in patients who require non-invasive ventilatory support following extubation on the Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. The purpose of this study is to answer a specific, clinically relevant question. That is whether Heliox21 helps to reduce the effort of breathing in the period following withdrawal of mechanically assisted ventilation in patients on the intensive care unit.
Read the detailed description
Failure to wean from mechanical ventilatory support occurs when the magnitude of respiratory system loading exceeds its capacity to respond. Extubation success depends on the condition being resolved or improved. Gas exchange capacity, respiratory muscle strength, laryngeal function and cough strength, nutritional status and psychological state can all lead to extubation failure. However, efforts to reduce the work of breathing might offer an alternative strategy.
Studies recently carried out in both paediatric and adult populations disclose the serious consequences of failed extubation, namely prolonged intensive care and hospital stays, greater mortality rates and increased care costs.
Gas flow in an airway can be either laminar or turbulent. There needs to be a greater pressure differential to drive a turbulent flow than a laminar one. Helium is an inert gas with no systemic biological effects (at standard temperature and pressure).
The low density and viscosity of Helium means that its substitution for nitrogen in air allows laminar flow to be maintained at much higher flow rates, and flow rates to be maintained at much lower working pressures (5). As a result, the use of helium-oxygen mixtures (Heliox21) has potential to reduce work of breathing, and also to limit dynamic gas trapping through increased cavity emptying, and altered lung mechanics/ forced expiratory pressures. As a result, Heliox21 has been used as a respiratory therapeutic bridge for over 30 years, with demonstrable advantage in the management of conditions including tracheal obstruction and chronic obstructive pulmonary disease (COPD).
In theory, the use of Heliox21 should reduce work of breathing by improving the balance between work demand and capacity during the process of weaning patients from mechanical ventilation. In general studies of the use of Heliox21 after extubation have been limited. Thus, we aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. Whilst Heliox21 has generally been administered through a simple face-mask (+/- rebreathing bag), the development of the HAMILTON G5 AVEA ventilator now allows the accurate administration of Heliox21 (21% helium/79% oxygen) with defined inspired fractional oxygen concentrations. This advent offers the means to safely administer helium as an adjunct to non-invasive ventilatory support.
Main inclusion criteria:
All patients with a predicted requirement for post extubation non-invasive ventilatory support continuous positive airway pressure/bilevel positive airway pressure/noninvasive ventilation(CPAP/BiPAP/NIV) will be eligible.
The primary outcome measure:
The difference between the frequency to tidal volume (f/VT) ratio* after four hours of Heliox21 and the f/VT ratio after four hours of Air O2.
- Conditions
- Respiratory Insufficiency
- Being tested
- Heliox21, Air O2
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heliox21Drug
For Heliox21 the percentage of O2 will match the percentage of O2 prior to extubation, and Helium will make up the remainder (e.g. Helium 65% + O2 35%), and the O2 concentration will be titrated as their clinical condition indicates (as O2 increases Helium will decrease and vice versa).
Air O2Drug
For Air-O2 the percentage of O2 delivered will match the patient's percentage of O2 prior to extubation, and will be titrated as their clinical condition indicates.
| Study group | Role | What they receive |
|---|---|---|
| Heliox21 | Experimental | Not described Receives: Drug: Heliox21 |
| Air O2 | Active comparator | Not described Receives: Drug: Air O2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the f/VT ratio*
*f/VT is the measurement of breathing rate to tidal volume (f/VT) ratio
Measured: After four hours of Heliox21 and after four hours of Air O2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Hargreaves, Study director, Whittington Hospital NHS TrustDaniel S Martin, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498432
- Sponsor's protocol ID
- 08/0339
- Other IDs
- 2009-009599-11, 2009
- Status last verified
- Dec 2011
- First submitted
- 20 Dec 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Single Centre, Single Blinded,Prospective Randomised Cross Over Comparison on the Physiological Response of Post Extubation Intensive Care Patients to Non-invasive Ventilation Using Either Air O2 or Heliox21
- ClinicalTrials.gov ID
- NCT01498432
- Acronym / sponsor ID
- 08/0339
- Conditions
- Respiratory Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-commercial study to explore the use of Heliox21 in a new patient cohort. The fundamental aim is to assess the therapeutic benefits of Heliox21 and practicalities of gas delivery in patients who require non-invasive ventilatory support following extubation on the Intensive Care Unit. Thus, the investigators aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. The purpose of this study is to answer a specific, clinically relevant question. That is whether Heliox21 helps to reduce the effort of breathing in the period following withdrawal of mechanically assisted ventilation in patients on the intensive care unit.
Detailed description
Failure to wean from mechanical ventilatory support occurs when the magnitude of respiratory system loading exceeds its capacity to respond. Extubation success depends on the condition being resolved or improved. Gas exchange capacity, respiratory muscle strength, laryngeal function and cough strength, nutritional status and psychological state can all lead to extubation failure. However, efforts to reduce the work of breathing might offer an alternative strategy.
Studies recently carried out in both paediatric and adult populations disclose the serious consequences of failed extubation, namely prolonged intensive care and hospital stays, greater mortality rates and increased care costs.
Gas flow in an airway can be either laminar or turbulent. There needs to be a greater pressure differential to drive a turbulent flow than a laminar one. Helium is an inert gas with no systemic biological effects (at standard temperature and pressure).
The low density and viscosity of Helium means that its substitution for nitrogen in air allows laminar flow to be maintained at much higher flow rates, and flow rates to be maintained at much lower working pressures (5). As a result, the use of helium-oxygen mixtures (Heliox21) has potential to reduce work of breathing, and also to limit dynamic gas trapping through increased cavity emptying, and altered lung mechanics/ forced expiratory pressures. As a result, Heliox21 has been used as a respiratory therapeutic bridge for over 30 years, with demonstrable advantage in the management of conditions including tracheal obstruction and chronic obstructive pulmonary disease (COPD).
In theory, the use of Heliox21 should reduce work of breathing by improving the balance between work demand and capacity during the process of weaning patients from mechanical ventilation. In general studies of the use of Heliox21 after extubation have been limited. Thus, we aim to extend our knowledge of the potential role for Heliox21 in the post-extubation environment of the Intensive Care Unit. Whilst Heliox21 has generally been administered through a simple face-mask (+/- rebreathing bag), the development of the HAMILTON G5 AVEA ventilator now allows the accurate administration of Heliox21 (21% helium/79% oxygen) with defined inspired fractional oxygen concentrations. This advent offers the means to safely administer helium as an adjunct to non-invasive ventilatory support.
Main inclusion criteria:
All patients with a predicted requirement for post extubation non-invasive ventilatory support continuous positive airway pressure/bilevel positive airway pressure/noninvasive ventilation(CPAP/BiPAP/NIV) will be eligible.
The primary outcome measure:
The difference between the frequency to tidal volume (f/VT) ratio* after four hours of Heliox21 and the f/VT ratio after four hours of Air O2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heliox21 | Experimental | Drug: Heliox21 |
| Air O2 | Active comparator | Drug: Air O2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged ≥ 18 years
- Males
- Females
- 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 (CPAP), BiLevel positive airway pressure (BiPAP) or non-invasive ventilation (NIV):
Key exclusion criteria (14 listed)
- Age < 18 years
- Patient/legal representative refusal or inability to consent
- Adults with learning disabilities/ dementia
- Any contraindication to non-invasive ventilation:
- Inability to use mask (trauma/surgery) Excessive secretions Haemodynamic instability/life threatening arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heliox21For Heliox21 the percentage of O2 will match the percentage of O2 prior to extubation, and Helium will make up the remainder (e.g. Helium 65% + O2 35%), and the O2 concentration will be titrated as their clinical condition indicates (as O2 increases Helium will decrease and vice versa). | Drug | Heliox21 |
| Air O2For Air-O2 the percentage of O2 delivered will match the patient's percentage of O2 prior to extubation, and will be titrated as their clinical condition indicates. | Drug | Air O2 |
Primary outcome
The difference between the f/VT ratio*
Time frame: After four hours of Heliox21 and after four hours of Air O2.
*f/VT is the measurement of breathing rate to tidal volume (f/VT) ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Hargreaves study director
Whittington Hospital NHS Trust
Daniel S Martin principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heliox21 and Air O2 in people with Respiratory Insufficiency, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel S Martin (02077940500 ext. 35047, rmhadam@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the f/VT ratio* (time frame: After four hours of Heliox21 and after four hours of Air O2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2011.