HOT-HMV2: A Phase 4 Study
Research type
Research Study
Full title
Home Oxygen Therapy - Home Mechanical Ventilation 2: A Phase 4 Study
IRAS ID
228411
Contact name
Nicholas Hart
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Smoking related lung disease or chronic obstructive pulmonary disease (COPD) is characterised by periods of worsening symptoms termed exacerbations. In some patients these may be severe enough to require hospitalisation and support for their breathing. Patients who suffer a severe exacerbation requiring breathing support have a high chance of being readmitted to hospital in the following 12 months. Recent evidence suggests that the provision of a breathing machine at home may reduce the risk of readmission to hospital in selected patients.
Following publication of the home oxygen therapy-home mechanical ventilation (HOT-HMV) trial, we will evaluate the clinical service delivery of home non-invasive ventilation (NIV) therapy in patients who have recently undergone, and recovered, from a life threatening exacerbation of COPD.
The study will assess the effectiveness of the clinical service delivery and it will not require any additional testing for patients. The outcome measures will include 12-month admission-free survival, 28-day readmission and self-reported health-related quality of life as measured by the Severe Respiratory Insufficiency questionnaire and the COPD assessment test. Breathlessness will be self-reported using the the MRC dyspnoea scale
REC name
London - Central Research Ethics Committee
REC reference
18/LO/0694
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion