RecruitingACTRN12608000103369

Spontaneous versus spontaneous timed mode of assisted ventilation in patients with chest wall disease and stable neuromuscular disease

Sponsor

Institute for Breathing And Sleep

Enrollment

20 participants

Start Date

May 1, 2008

Study Type

Interventional

Conditions

Chest wall disease Neuromuscular disease

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two modes of ventilation (breathing support machines) used at night for people with breathing difficulties caused by chest wall problems — like a curved spine (kyphoscoliosis) — or stable neuromuscular diseases (conditions affecting the muscles or nerves that control breathing). The two modes differ in how the machine delivers breaths. There is currently no strong evidence that one is better than the other. The study will compare how well each mode keeps breathing in check and how well people sleep on each one. You may be eligible if: - You are 18 years of age or older - You have chest wall disease (such as kyphoscoliosis) or a stable neuromuscular disease - You already use a ventilator (breathing machine) at night - Your daytime carbon dioxide level was elevated when you first started using the machine You may NOT be eligible if: - You have COPD (Chronic Obstructive Pulmonary Disease) - You have a progressive neuromuscular disease (such as motor neurone disease) - You have a tracheostomy - You are unable to provide informed consent Talk to your doctor about whether this trial might be right for you.

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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 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.

Locations(1)

Australia

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ACTRN12608000103369