Home oxygen therapy versus home mechanical ventilation for chronic obstructive pulmonary disease
| ISRCTN | ISRCTN28058693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28058693 |
| ClinicalTrials.gov number | NCT00990132 |
| Secondary identifying numbers | 8059 |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 05/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases usually caused by smoking. When symptoms become particularly bad this is called an exacerbation. Some exacerbations of COPD can be very severe and patients need support from breathing machines (ventilators) in addition to oxygen therapy. Previous studies have examined whether the use of a ventilator at home, termed home mechanical ventilation, could help improve people’s breathing and reduce the need for readmission to hospital, but these studied have not been able to demonstrate a benefit. This is thought to be due to the poor design of the studies rather than failure of the ventilator itself. This study is a UK-wide study to investigate if home mechanical ventilation in addition to home oxygen therapy is better than home oxygen therapy on its own.
Who can participate?
Patients aged 18 or older who have had a life-threatening COPD exacerbation at least 2 weeks ago
What does the study involve?
Participants are randomly allocated to receive home oxygen therapy with or without home mechanical ventilation. They are followed up for 12 months to see if patients who received home mechanical ventilation have fewer hospital admissions.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
St Thomas's Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2009 to June 2016
Who is funding the study?
1. Guy's and St. Thomas' Charity (UK)
2. Respironics, Inc. (USA)
3. ResMed Ltd (Australia)
Who is the main contact?
Dr Patrick Murphy
Contact information
Scientific
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised interventional multicentre treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised controlled trial of home mechanical ventilation in hypercapnic chronic obstructive pulmonary disease patients post acute hypercapnic exacerbation |
| Study acronym | HOT HMV in COPD |
| Study objectives | The trial is designed to test the hypothesis that the use of home non-invasive ventilation (NIV) in persistently hypercapnic chronic obstructive pulmonary disease (COPD) patients following an acute hypercapnic exacerbation of COPD reduces hospital admissions and improves survival. |
| Ethics approval(s) | St Thomas' Hospital Research Ethics Committee, 12/06/2009, ref: 09/H0802/2 |
| Health condition(s) or problem(s) studied | Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory |
| Intervention | 1. Domiciliary non-invasive ventilation (HMV) 2. Home oxygen therapy (HOT) Follow up length: 12 month(s) Study entry: Single randomisation only |
| Intervention type | Other |
| Primary outcome measure | Admission-free survival up to 12 months |
| Secondary outcome measures | Measured at 6 weeks, 3 months, 6 months, 12 months: 1. Daily activity - actigraphy 2. Exercise tolerance 3. Pulmonary mechanics 4. Respiratory muscle strength 5. Sleep quality - actigraphy |
| Overall study start date | 01/10/2009 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 116; UK Sample Size: 116 |
| Key inclusion criteria | 1. Acute hypercapnic exacerbation of COPD at least 2 weeks previously 2. In patient admission with acute hypercapnic respiratory failure 3. Smoking greater than 20 pack year history 4. Forced expiratory volume in one second (FEV1) less than 50% 5. FEV1/forced vital capacity (FVC) less than 60% 6. Chronic hypercapnia (PaCO2 greater than 7 kPa) 7. Chronic hypoxia PaO2 less than 7.3 kPa or less than 8 kPa with secondary polycythaemia, pulmonary hypertension, peripheral oedema or significant nocturnal hypoxia (SpO2 less than 90% for greater than 30% sleep time) 8. Aged 18 years or older, either sex |
| Key exclusion criteria | 1. Unable to wean off NIV prior to discharge (persistent hypercapnic respiratory failure with pH less than 7.30) 2. Post extubation or decanulation 3. Body mass index (BMI) greater than 35 kg/m^2 4. Primary diagnosis of restrictive lung disease causing hypercapnia 5. Development of worsening hypercapnic respiratory failure with acidosis during initiation of oxygen therapy (ABG - pH less than 7.30 taken 2 - 4 hours after waking) 6. Unable to tolerate NIV (if given) during acute illness 7. Unstable coronary artery syndrome 8. Renal replacement therapy 9. Inability to consent/comply with trial protocol (as determined by site PI) 10. Aged less than 18 years 11. Pregnant |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
4th Floor
Thomas Guy House
Lambeth Palace Road
London
SE1 7EH
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Industry
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study will be analysed and prepared for publication in a scientific journal and presentation at international conferences such as the European respiratory congress. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to institution policy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/06/2017 | Yes | No |
Editorial Notes
05/06/2017: Publication reference added.
12/08/2016: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/09/2010 to 30/06/2016.
2. Plain English summary added.
