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Randomized Controlled Trial Multicenter Study
"A randomized trial of initiation of chronic non-invasive mechanical ventilation at home vs in-hospital in patients with Neuromuscular Disease and thoracic cage disorder": The Dutch Homerun Trial.
- van den Biggelaar Ries J M RJM Department of Pulmonary Diseases/Department of Intensive Care Medicine and Home Mechanical Ventilation, Erasmus Medical Center Rotterdam, T, Anda Hazenberg, Nicolle A M Cobben, Michael A Gaytant, Karin M Vermeulen, and Peter J Wijkstra.
- Department of Pulmonary Diseases/Department of Intensive Care Medicine and Home Mechanical Ventilation, Erasmus Medical Center Rotterdam, The Netherlands. Electronic address: r.vandenbiggelaar@erasmusmc.nl.
- Chest. 2020 Dec 1; 158 (6): 2493-2501.
BackgroundThere is an increasing demand for home mechanical ventilation (HMV) in patients with chronic respiratory insufficiency. At present, noninvasive ventilation is exclusively initiated in a clinical setting at all four centers for HMV in the Netherlands. In addition to its high societal costs and patient discomfort, commencing HMV is often delayed because of a lack of hospital bed capacity.Research QuestionIs HMV initiation at home, using a telemonitoring approach, noninferior to in-hospital initiation in a nationwide study?Study Design And MethodsWe conducted a nationwide, randomized controlled noninferiority trial, in which every HMV center recruited 24 patients (home [n = 12] vs hospital [n = 12]) with a neuromuscular disease or thoracic cage disorder, all with an indication to start HMV. Change in arterial CO2 (Paco2) over a 6-month period was considered the primary outcome, and quality of life and costs were assessed as secondary outcomes.ResultsA total of 96 patients were randomized, most of them diagnosed with neuromuscular disease. We found a significant improvement in Paco2 within both groups (home: from 6.1 to 5.6 kPa [P < .01]; hospital: from 6.3 to 5.6 kPa [P < .01]), with no significant differences between groups. Health-related quality of life showed significant improvement on various subscales; however, no significant differences were observed between the home and hospital groups. From a societal perspective, a cost reduction of more than €3,200 ($3,793) per patient was evident in the home group.InterpretationThis nationwide, multicenter study shows that HMV initiation at home is noninferior to hospital initiation, as it shows the same improvement in gas exchange and health-related quality of life. In fact, from a patient's perspective, it might even be a more attractive approach. In addition, starting at home saves over €3,200 ($3,793) per patient over a 6-month period.Trial RegistryClinicalTrials.gov; No.: NCT03203577; URL: www.clinicaltrials.gov.Copyright © 2020. Published by Elsevier Inc.
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