Initiation of home mechanical ventilation at home in a selectve group of patients with chronic hypercapnic respiratory failure in the Netherlands.

• Conditions: Chronic ventilatory support; home mechanical ventilation; non-invasive ventilation; neuromuscular disease; thoracic cage problem; telemonitoring; cost-effectivenessChronische ademhalingsondersteuning; thuisbeademing; niet invasieve beademing; neuromusculaire ziekte, thorax kooi probleem

• Registration Number: NL-OMON26822
• Lead Sponsor: niversital Medical Center GroningenMaastricht Universital Medical CenterUniversital Medical Center UtrechtErasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

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

Exclusion Criteria

- Patients who already have had HMV due to acute respiratory failure

- Necessity for invasive ventilatory support

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective:<br /><br>- Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position<br>

Secondary Outcome Measures

Name	Time	Method
Secondary objective:<br /><br>- Health related quality of life<br /><br>- Lung function<br /><br>- Nocturnal transcutaneous carbon dioxide and saturation<br /><br>- Costs<br>