|- candidate number||18323|
|- NTR Number||NTR4683|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-jul-2014|
|- Secondary IDs||ZonMw 80-83700-98-52003 METc|
|- Public Title||Initiation of home mechanical ventilation at home in a selectve group of patients with chronic hypercapnic respiratory failure in the Netherlands.|
|- Scientific Title||Initiation of home mechanical ventilation at home in a selectve group of patients with chronic hypercapnic respiratory failure in the Netherlands.|
|- hypothesis||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. |
It is a randomised controlled parallel study with a non- inferiority design comparing the start of HMV at home with the start of HMV in a hospital based setting.
|- Healt Condition(s) or Problem(s) studied||Ventilation, Neuromuscular diseases, Cost-effectiveness , Mechanical ventilation, Telemonitoring|
|- 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
- 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.
|- Exclusion criteria||- Patients who already have had HMV due to acute respiratory failure|
- Necessity for invasive ventilatory support
- Patients admitted to a nursing home
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-dec-2014|
|- planned closingdate||1-jun-2018|
|- Target number of participants||96|
|- Interventions||The proposed intervention to be studied is initiation of HMV at home as compared to in hospital initiation I 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. We found that initiation of HMV at home in a selected group under strict supervision of a HMV center seemed effective, safe, and probably 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.. |
|- Primary outcome||Primary objective:|
- Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position
|- Secondary outcome||Secondary objective:|
- Health related quality of life
- Lung function
- Nocturnal transcutaneous carbon dioxide and saturation
|- Timepoints||0– 6 months: METc approval, train de trainer meetings, building database|
6 - 30 months: inclusions of patients, expert meeting, process evaluation
30 months: last patient included, expert meeting, process evaluation
30 – 36 months: writing first paper on baseline assessments
36 months: last patient out of study
36 – 42 months: finalising study, expert meeting and writing paper for thesis
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Nurse Practitioner Anda Hazenberg|
|- CONTACT for SCIENTIFIC QUERIES||Nurse Practitioner Anda Hazenberg|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Maastricht University Medical Center (MUMC+), University Medical Center Utrecht (UMCU), Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Vivisol Nederland B.V.|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||9-jul-2014 - 10-aug-2014|