NCT03203577

Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure

Initiation of Home Mechanical Ventilation at Home in a Selectve Group of Patients With Chronic Hypercapnic Respiratory Failure in the Netherlands

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start. Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation. Study design: A nationwide non-inferiority multi-center randomized parallel active control study. Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support. Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline. Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total. Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months. Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.

Conditions

• Respiratory Therapy
• Respiration, Artificial
• Positive-Pressure Respiration
• Neuromuscular Diseases
• Noninvasive Ventilation
• Cost-Benefit Analysis
• Ambulatory Monitoring

Interventions

Type	Name	Description
PROCEDURE	Initiation of mechanical ventilation	In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-01
• Completion: 2018-05-01
• First posted: 2017-06-29
• Last updated: 2018-06-18

Locations

1 site across 1 country: Netherlands