We are recruiting volunteers who have recently been admitted to hospital with an exacerbation of chronic obstructive pulmonary disease (COPD), which required oxygen and mask ventilation, to take part in the ‘home mechanical ventilation in hypercapnic chronic obstructive pulmonary disease (COPD) patients post-acute hypercapnic exacerbation’ (HOT-HMV) trial.
You will be invited to participate in the HOT-HMV trial two weeks after your admission to hospital at which point we will assess whether you will require oxygen at home. If you do, we will invite you to join the trial.
About the study
Currently, oxygen therapy is the standard treatment for your lung disease. However, not all patients can tolerate oxygen therapy and some patients are sensitive to oxygen therapy causing their waste gas, carbon dioxide, to rise. This study is being carried out to determine whether oxygen therapy alone or oxygen therapy with mask ventilation reduces your risk of readmission to hospital and improves your exercise capacity and quality of life.
If you are eligible for this study and are happy to take part, you will be randomly (like tossing a coin) assigned to receive either oxygen therapy alone or oxygen therapy with mask ventilation. The mask ventilator is a standard piece of clinical equipment used by many patients and is similar to the one you used during your recent illness. However, it will generally be smaller, quieter and the mask is more comfortable for long-term use. You will be admitted to hospital for 1-2 days in order to start the treatment.
Tests will be done at the start of the study and at six weeks, three months, six months and 12 months. These tests are pain free, except the blood test which can be uncomfortable. A sleep study where oxygen and carbon dioxide levels are measured overnight, which is a routine clinical test will be performed at the start of the study. This involves a finger probe and a small patch monitor on the skin. Both are painless.
Find out more by reading our patient information sheet (Word 111Kb) and our data processing sheet (Word 14Kb).
Benefits and disadvantages of participating
We do not perceive any disadvantages in taking part as all patients will receive the current ‘best practice’ therapy. This study will require time and commitment from the patients enrolled, which the investigators wholly appreciate and are grateful, with the patients being followed up closely. The research team has an extensive depth of knowledge in management of patients with COPD.
We are keen that there are no risks to taking part in this study. We have included safety measures within the protocol and the study will not only be under the guidance of the steering group and trial management group but also we have a data monitoring committee, whose job it is to not only ensure that the trial is well managed, but also this group will monitor safety.
The benefits of oxygen therapy alone are well known and include improving survival. However, the effects of oxygen therapy and mask ventilation have not been fully determined and that is the reason for carrying out this study. The potential benefits include:
- reduce risk of re-admission to hospital
- reduce symptoms and exacerbation frequency
- improved mood and quality of life
- improved sleep
- less fatigued and tired
- walk further.
How to get involved
We have now recruited 116 patients with Chronic Obstructive Pulmonary Disease (COPD) and so this trial is now closed. For further information please contact the Principle Investigator Dr Patrick Murphy on firstname.lastname@example.org.
All participants were recruited from across 15 sites in the UK. Guy’s and St Thomas’ NHS Foundation Trust were the sponsors of the trial.
The results are available at the following links: