Helium-oxygen reduces the work of breathing during weaning from mechanical ventilation
| ISRCTN | ISRCTN56470948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56470948 |
| EudraCT/CTIS number | 2005-003612-30 |
| Secondary identifying numbers | REC ref: 05/Q0605/150 |
- Submission date
- 02/01/2009
- Registration date
- 30/01/2009
- Last edited
- 04/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gordon Flynn
Scientific
Scientific
Intensive Care Unit
Prince of Wales Hospital
Sydney
2031
Australia
| docgordonflynn@yahoo.co.uk |
Study information
| Study design | Prospective randomised controlled cross-over single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | A comparison of a helium-oxygen mixture (Heliox) with an oxygen air mixture in reducing the work of breathing during weaning from mechanical ventilation |
| Study objectives | There is evidence in patients with chronic obstructive pulmonary disease (COPD) that around the period of extubation helium-oxygen leads to a reduction in the work of breathing. In a small physiological study in patients without airways disease, breathing helium-oxygen during weaning decreased the work of breathing. If so, could there be a use for helium in the weaning of patients from mechanical ventilation? |
| Ethics approval(s) | East London & The City HA Local Research Ethics Committee 3, approved on 09/11/2005 (ref: 05/Q0605/150) |
| Health condition(s) or problem(s) studied | Work of breathing during weaning from mechanical ventilation |
| Intervention | This is a single-centre trial carried out at The Royal London Hospital. Intervention: Helium inhaled at a concentration no less than 60%. Patients received 2 hours of continuous positive airway pressure (CPAP) ventilation (positive end-expiratory pressure [PEEP] setting remained unchanged and pressure support set to zero) with helium-oxygen or air-oxygen via an eVent ventilator. This ventilator was calibrated for the helium oxygen mixture on an individual patient basis. Patients were returned to their pre-study ventilator settings for 2 hours, before being given the alternative gas mixture for 2 hours. The level of CPAP support and FiO2 were unchanged for individual patients throughout the trial period. |
| Intervention type | Other |
| Primary outcome measure | Work of breathing measured by carbon dioxide production. Measurements were taken continuously but presented before starting CPAP and helium then 1 hour later then at 2 hours, patient then returned to pre-CPAP ventilator settings for 2 hours then back on CPAP with alternate gas mixture with readings taken continuously but presented at 1 and 2 hours. |
| Secondary outcome measures | 1. Respiratory rate 2. Pulse oximetry (SpO2) 3. Alveolar minute ventilation 4. Alveolar tidal volume 5. CO2 production 6. End tidal CO2 7. Alveolar dead space (Vd/Vt) Above measurements were taken continuously but presented before starting CPAP and helium then 1 hour later then at 2 hours, patient then returned to pre-CPAP ventilator settings for 2 hours then back on CPAP with alternate gas mixture with readings taken continuously but presented at 1 and 2 hours. |
| Overall study start date | 01/01/2006 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. General adult intensive care unit (ICU) patients 2. Both males and females, aged between 18 and 80 3. The underlying cause of respiratory failure was improving 4. Pressure support ventilation of less than 10 cm H2O 5. No continuous intravenous sedation or inotropes 6. FiO2 less than or equal to 0.4 and requiring less than 10 cm H2O positive end expiratory pressure 7. Written informed consent from the patient or assent from their next of kin was obtained |
| Key exclusion criteria | 1. Failure to meet inclusion criteria 2. Inadequate analgesia 3. Pregnancy 4. Participation in other intervention trials in the past 30 days 5. Refusal of consent from the patient or assent from the next of kin |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Australia
- United Kingdom
Study participating centre
Intensive Care Unit
Sydney
2031
Australia
2031
Australia
Sponsor information
Barts and The London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Gerry Leonard
Research and Development Department
Third Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
England
United Kingdom
| Website | http://www.bartsandthelondon.org.uk |
|---|---|
"ROR" |
https://ror.org/00b31g692 |
Funders
Funder type
Government
Barts and the London NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/08/2010 | Yes | No |
