"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

Ries J M van den Biggelaar*, Anda Hazenberg, Nicolle A M Cobben, Michael A Gaytant, Karin M Vermeulen, Peter J Wijkstra

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Scopus)

Abstract

Background: There 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 Question: Is HMV initiation at home, using a telemonitoring approach, noninferior to in-hospital initiation in a nationwide study? Study Design and Methods: We 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 CO 2 (PaCO 2) over a 6-month period was considered the primary outcome, and quality of life and costs were assessed as secondary outcomes. Results: A total of 96 patients were randomized, most of them diagnosed with neuromuscular disease. We found a significant improvement in PaCO 2 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. Interpretation: This 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 Registry: ClinicalTrials.gov; No.: NCT03203577; URL: www.clinicaltrials.gov;

Original languageEnglish
Pages (from-to)2493-2501
Number of pages9
JournalChest
Volume158
Issue number6
Early online date16-Jul-2020
DOIs
Publication statusPublished - Dec-2020

Keywords

  • neuromuscular disease
  • noninvasive ventilation
  • telemedicine
  • thoracic cage abnormality

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