A Randomized Trial of Initiation of Chronic Noninvasive Mechanical Ventilation at Home vs In-Hospital in Patients With Neuromuscular Disease and Thoracic Cage Disorder: The Dutch Homerun Trial

Chest. 2020 Dec;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007. Epub 2020 Jul 16.

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 CO2 (Paco2) 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 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.

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.

Keywords: neuromuscular disease; noninvasive ventilation; telemedicine; thoracic cage abnormality.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Gas Analysis / methods
  • Female
  • Home Care Services* / economics
  • Home Care Services* / statistics & numerical data
  • Hospitalization* / economics
  • Hospitalization* / statistics & numerical data
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Physiologic / methods
  • Netherlands
  • Neuromuscular Diseases* / blood
  • Neuromuscular Diseases* / complications
  • Neuromuscular Diseases* / psychology
  • Noninvasive Ventilation / methods*
  • Outcome and Process Assessment, Health Care
  • Quality of Life*
  • Respiratory Insufficiency* / diagnosis
  • Respiratory Insufficiency* / etiology
  • Respiratory Insufficiency* / physiopathology
  • Respiratory Insufficiency* / therapy
  • Telemedicine / methods*
  • Thoracic Diseases* / blood
  • Thoracic Diseases* / complications
  • Thoracic Diseases* / psychology

Associated data

  • ClinicalTrials.gov/NCT03203577