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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43736

Enrollment

Registered

2015-03-30

Start date

2015-07-28

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuromuscular disease / thoracic cage problem

Interventions

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 initi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position, at baseline and 6 months follow-up	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)