Initiation of chronic ventilatory support outside the hospital.

Telecare and telecure are promising new features for chronic patients as it
probably can decrease the costs of healthcare while it improves quality of life
at the same time.
Nocturne was a successful telemedicine pilot showing that patients using
haemodialysis can be treated effectively outside the hospital. In the present
study we want to investigate if is possible to initiate Home Mechanical
Ventilation in the patients* homes. Points of interest during this pilot are
the innovative process, the necessary telemonitoring and the organisation of
the professionals. In the Netherlands there are ca. 1600 patients (October
2007) on home mechanical ventilation of which 360 is treated in Groningen.
These are mainly patients with neuromuscular diseases or ribcage abnormality
which suffer from chronic respiratory failure. This number shows a rising
development where particularly the increase of patients with Amyotrofische
lateral sclerosis (ALS) is striking over the previous years. Ten percent of
the 360 patients who get chronic ventilatory support in Groningen are patients
with ALS, whereas this percentage was in the 2001 5%. A further increase in the
future is possible caused by the slaapapneu patients . End 2004 approximately
20,000 patients in the Netherlands were treated with slaapapneu, in literature
it is indicated that no less than 2-4% of the population have this. Finally the
indication for Chronic Obstructive Pulmonary Disease (COPD) is at present
examined. If it is shown that also in this group chronic ventilatory support
effective is, the demand for this therapy strongly will increase. The
prevalence of COPD will increase of 1995 up to 2015 with 59% at the men,
whereas this even increases at the women with 123% . Therefore new methods are
needed to prepare on patients who have to start with chronic ventilatory
support.

We want to investigate if it is possible to set up the entire process of home
mechanical ventilation outside the hospital. This means practically that the
patients will not be admitted to the hospital. The goal of this study is to
answer the following questions:
1.Is initiation of mechanical ventilation at home equally effective in
improving gas exchange as compared to the initiation of it in the hospital?
2.Is initiation of mechanical ventilation at home equally effective in
improving quality of life as compared to the initiation of it in the hospital?
3.What kind of organisation- communication and infrastructure is necessary to
start home mechanical ventilation monitored by telecare?
4.Is initiation of mechanical ventilation at home more cost effective as
compared to the initiation of it in the hospital?

Primary objective:
- blood gas analysis: PaCO2 and PaO2
Secondary objective:
- Health related quality of life
- costs
- social environment, Intermed
- telemedicine

Seventy six patients will be randomized, open character, for either ventilatory
support at home (group A, n=38, intervention group) or for initiation of it in
the hospital (group B, n=38). After this start group A will continue
ventilatory support at home and will be controlled after 8 weeks by
transcutaneous assessment during the night. Group B will go home and will be
readmitted after 8 weeks to control the effectiveness of ventilatory support by
arterial blood gasses on the ICU. Thereafter both groups will be supervised by
a nurse consultant at home. At the outpatient clinic the effectiveness of
ventilatory support will be performed by arterial blood gas. We believe it will
take18 months to include the number of patients needed for this study.

The start of chronic ventilatiry support will be in the hospital ( standard
care) or at home ( telecare)

At home there is no professional caretaker permanently present to supervise the
initiation of the ventilatory support in contrast to the situation if patients
start their ventilatory support in hospital. However, we are trying to
supervise the patients better by providing telemonitoring at home, and more
important we believe that the risks are within acceptable limits as it is not
dangerous for the patients if they are not ventilated adequately from the
beginning. In the normal in-hospital situation it takes up to a week to get
the ventilatory support at a sufficient level. The extra burden for the
patients being in this project is filling in 3 different quality of life
questionnaires. At baseline, after 2 and 6 months.
Other important benefits of starting ventilatory support at home are:
- It is for the patients far more convenient if they can stay at home for this
period as the social and (para) medicalsupport is normally much better
organised and even individually tailored which is mostly not the case in
hospital.
- No arterial line at baseline and after two months
- No re-admittance after 2 months of ventilatory support