HOMERUN
Initiation of HOme MEchanical ventilation at home in a selective group of patients with chronic hypercapnic Respiratory failUre in the Netherlands

Home mechanical ventilation (HMV) in the Netherlands routinely starts in a
clinical setting supervised by the regional HMV center, as recommended in the
national guideline which typically requires several days, up to a week of
hospitalization. Depending on the local organization this can be done on
different wards varying from the intensive care unit in Rotterdam, a medium
care in Maastricht and Utrecht to a specifically developed respiratory ward as
part of a rehabilitation center in Arnhem. In Groningen patients are admitted
to a regular respiratory ward and are transferred for one night to the
intensive care unit (ICU) for nocturnal invasive blood gas analysis. These in
hospital initiations of HMV are not only an expensive way of starting HMV, but
also very inconvenient to this group of patients. Especially in patients who
are severely disabled and around whom a home care team already exists, the
initiation of HMV at home within this team would be a major improvement. In
Groningen we performed a pilot study (EOLUS) in which we showed that initiation
of HMV at home in a selected group of patients is equally effective and saves
costs compared to inpatient initiation. Still, in EOLUS we compared only the
home setting with the Groningen in hospital model and not with the other 3
models. In addition in the Dutch guideline on chronic ventilation it is stated
that chronic ventilation has to be started inpatient. To change this guideline
and to investigate the cost-effectiveness of initiation of HMV at home
nationwide, we have to do the same comparison in the other 3 centers.
Our hypothesis is that initiation of HMV at home, by using telemonitoring, in
patients with chronic respiratory failure due to neuromuscular disease (NMD) or
thoracic cage problem is not inferior compared to the start of it in a hospital
based setting. In addition we believe that the start at home is safe and
cheaper compared to an in-hospital start. The primary outcome measure is the
arterial carbon dioxide (PaCO2) while quality of life and cost-effectiveness
are secondary outcomes measurements.

Patients with chronic respiratory failure currently start their ventilatory
support in hospital as stated in national guideline. However, as these patients
are severely disabled, a stay at the hospital for several days is experienced
by many as very uncomfortable and distressing. Secondly, at home the care of
these patients is organized by a dedicated multidisciplinary team, with less
variation in caregivers than in hospital. Thirdly, costs for an in hospital
start of the ventilatory support are much higher than at home.

This is a multi-center, prospective, randomized, active controlled study with a
non-inferiority design. Ninety-six patients will be randomized for either
initiating ventilatory support at home (home group) or in the hospital
(hospital group). The home group will start their chronic ventilatory support
at home being supervised by a registered nurse of a department of home
mechanical ventilation (HMV) who will visit them at home. Patients who are
randomized for the hospital group will start chronic ventilatory support
according to the local standards of their HMV center in the hospital setting.
The different steps are carefully described in a protocol in what way the
ventilatory support should be adjusted (ventilator settings and therapeutic
decisions) in a standardized procedure. After the start, the home group will
continue chronic ventilatory support at home while the effectiveness of this
treatment will be monitored only non-invasively. In the hospital group chronic
ventilatory support will be monitored invasively or non-invasively during the
night. In both groups, six months after the initiation of the chronic
ventilatory support, the effectiveness will be assessed by arterial blood gas
analysis at the outpatient clinic. In addition we will assess nocturnal
transcutaneous carbon dioxide, costs, lung function and health related quality
of life.

The proposed intervention to be studied is initiation of HMV at home as
compared to in hospital initiation in different settings. Recently a pilot
study was performed in Groningen in which the initiation of HMV at home was
compared with an in hospital start. They found that initiation of HMV at home
in a selected group under strict supervision of a HMV center was effective,
safe, and cost-effective compared to inpatient initiation. These results need
to be duplicated and extrapolated to other models of initiation in the hospital
than the Groningen model. We will therefore perform a similar study, in all
four existing centers for home mechanical ventilation in the Netherlands.
The ventilator being used in the home group is the same as in the hospital
group. In the home group telemedicine is used to transfer information to the
hospital for the delivery of clinical care. Every morning during the initiation
period of HMV at home, the data of the ventilator will be sent to the hospital.
The RN receives by email these digital data, not being traceable without the
subject indentification code list, and will phone the patient to evaluate the
results. We will use the Dyna-Vision* which is a patient monitor with built-in
mobile technology that can send digital data to every location under secure
conditions In this way it transfers the information collected by the ventilator
and transcutaneous monitor to the hospital. The digital data comprises of
ventilator settings, respiratory rate and carbon dioxide and oxygen saturation
levels.

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. The results of the pilot study EOLUS indicate that initiation of HMV
at home is safe and technically feasible10.
The new intervention provides a number of important benefits compared to the
usual inpatient procedure. As the patients referred for HMV are severely
disabled, the care of these patients at home is organized by a dedicated
multidisciplinary team, with little variation in caregivers. For example in
severely disabled patients with Amyotrophic Lateral Sclerosis the start of HMV
at home with the help of such a team is easier than in hospital where the
number of health care providers is more variable. Another advantage of starting
HMV at home is that everyone who is involved in the care of this patient starts
at the same time to learn and work with HMV. In this way they get gradually
adjusted to the new situation with the ventilator at home.
Transcutaneous monitoring, during the night at home, will be used to measure
skin-surface PO2 and PCO2 to provide estimates of arterial partial pressure of
oxygen and carbon dioxide (PaO2 and PaCO2). The SenTec* is suitable for spot
check as well as long term measurements of up to 12 hours.
The ventilator being used in the home group is the same as in the hospital
group. In the home group telemedicine is used to transfer information to the
hospital for the delivery of clinical care. Every morning during the initiation
period of HMV at home, the data of the ventilator will be sent to the hospital.
The RN is able to look into this digital data, not being tracebale without the
subject identification code list, and will phone the participant to evaluate
the results. We will use the Dyna-Vision* and Carecom* both being patient
monitors with built-in mobile technology that can send digital data to every
location under secure conditions 11. In this way it transfers the information
collected by the ventilator and transcutaneous monitor to the hospital. The
digital data comprises of ventilator settings, respiratory rate and carbon
dioxide and oxygen saturation levels.
There will be no potential risks associated with the procedure to patients
participating in this clinical study.