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

Completed

Conditions: neuromuscular disease / thoracic cage problem
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10029317
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Registration Number: NL-OMON43736

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 96

Inclusion Criteria

The study will be set up in patients with chronic respiratory failure who were referred to a HMV center to start chronic ventilatory support.
Indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements:
-arterial carbon dioxide > 6.0 kPa daytime or arterial or transcutaneous carbon dioxide > 6.0 kPa at night or orthopnea as a result of diaphragm paralysis
-age > 18 years
-existence, of a sufficient network (social or professional) according to the supervising HMV center making initiation of HMV at home possible and safe.
-Informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Patients who previously used non-invasive ventilation
-Necessity for invasive ventilatory support
-Patients admitted to a nursing home

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation<br /><br>and ventilatory support while the patient is in sitting position, at baseline<br /><br>and 6 months follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life (SF 36, MRF 28, HADS, SRI, ALSFRSr, Edmonton Symptom<br /><br>Assessment Scale (ESAS), Care dependency Scale (CDS), Family Appraisal of<br /><br>Caregiver Questionnaire for Palliative Care (FACQ-PC), Inventory of complicated<br /><br>grief (ICG), Self-rating inventory for posttraumatic stress disorder (SRIP),<br /><br>Quality of death and dying (QODD), Quality of end-of-life care from the family<br /><br>perspective (Toolkit After-Death Bereaved Family Member Interview), process<br /><br>evaluation and the EQ-5D)<br /><br>- Lung function (if applicable)<br /><br>- Telemedicine<br /><br>- Costs (CRF and cost questionnaire)<br /><br>- Process evaluation (interview and questionnaire)<br /><br>- Palliative care and bereavement (interview and questionnaire)</p><br>