None listed
Conditions
Brief summary
The study aims to compare 2 commonly used modes of ventilation in patients with respiratory failure from neuromuscular disease or chest wall disease such as kyphoscoliosis. The study population will be patients already on mechanical ventilation to assist their breathing. As there is no current evidence that one treatment is better than the other, we wish to study the 2 ventilation modes in a crossover design (i.e. one treatment will be followed by the other on each patient) with regards to efficacy of ventilation and sleep quality on each mode. The study hypothesis is that there is no difference between the 2 modes (called the null hypothesis). The study will then attempt to prove whether this is true (i.e. accept the null hypothesis meaning that there is no difference), or false (i.e. reject the null hypothesis meaning that there is a difference between the 2 modes ). The study will help in the long term to determine which mode is more efficacious and comfortable to the patients with neuromuscular or chest wall disease.
Interventions
We aim to compare 2 commonly used modes of ventilation in patients with respiratory failure from either neuromuscular disease or chest wall disease, such as kyphoscoliosis. The first mode is called "spontaneous mode of pressure supported mechanical ventilation"; where the patient would trigger the ventilator totally on his/ her own; and the second is called "spontaneous timed mode of pressure supported mechanical ventilation"; where the ventilator has a set breath rate but also allows him or her
We aim to compare 2 commonly used modes of ventilation in patients with respiratory failure from either neuromuscular disease or chest wall disease, such as kyphoscoliosis. The first mode is called "spontaneous mode of pressure supported mechanical ventilation"; where the patient would trigger the ventilator totally on his/ her own; and the second is called "spontaneous timed mode of pressure supported mechanical ventilation"; where the ventilator has a set breath rate but also allows him or her to trigger the ventilator as required. The target population are patients with respiratory failure from neuromuscular disease and chest wall disease, who are already on mechanical ventilation usually in one of these 2 modes described. The patients will remain on each mode of ventilation for a period of 2 weeks, which is followed by a sleep study to assess efficacy of ventilation and sleep quality on each mode. They will also fill out a standardised questionnaire asking them, which mode caused any discomfort, and which one they prefered?. A washout period of 2 weeks will follow the initial mode when the participants will go back on their original ventilator.
Sponsors
Institute for Breathing And Sleep
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- Patients with chest wall disease such as kyphoscoliosis or stable neuromuscular disease will be eligible - Patients have evidence of hypoventilation (defined as day time PaCO2 of > 45 mmHg) at the time of initiation of ventilatory support. - Patients are already on nocturnal assisted ventilation
Exclusion criteria
- Patients aged less than 18 years of age - Patients with Chronic Obstructive Pulmonary Disease (COPD) - Patients with progressive neuromuscular disease such as motor neurone disease - Patients with a tracheostomy in situ - Patients in whom we are unable to obtain informed consent
Outcome results
None listed