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Randomized Controlled Trial
. 2020 Mar;75(3):244-252.
doi: 10.1136/thoraxjnl-2019-213303. Epub 2019 Sep 4.

Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial

Marieke L Duiverman  1   2 , Judith M Vonk  2   3 , Gerrie Bladder  4   2 , Joost P van Melle  5 , Jellie Nieuwenhuis  4   2 , Anda Hazenberg  4   2 , Huib A M Kerstjens  4   2 , Job F M van Boven  2   6 , Peter J Wijkstra  4   2
Affiliations
Randomized Controlled Trial

Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial

Marieke L Duiverman et al. Thorax. 2020 Mar.

Abstract

Introduction: Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.

Methods: Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO2) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.

Results: Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO2 change home vs in-hospital: 0.04 kPa (95% CI -0.31 to 0.38 kPa), with both groups showing a PaCO2 reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546-€4163) vs in-hospital: median €8537 (IQR €7540-€9175); p<0.001).

Discussion: This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.

Trial registration number: NCT02652559.

Keywords: COPD; non-invasive ventilation; telemedicine.

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Conflict of interest statement

Competing interests: MLD reports a grant from the Dutch Lung Foundation (junior investigator grant number 5.2.15.057JO) and the Philips Respironics, Murrysville, Pennsylvania, USA, provided for the conduct of the present study. Furthermore, MLD received grants and personal fees from Vivisol B.V., grants from Fisher and Paykel Ltd, and personal fees from Philips, outside the submitted work. JMV, GB, AH, JN, JPvM and JFMvB have no competing interests. HAMK reports an unrestricted research grant and fees for participation in advisory boards from Boehringer Ingelheim, Novartis and GlaxoSmithKline, and fees for advisory board participation from AstraZeneca and Chiesi, all above paid to his institution and outside the submitted work. PJW reports grants and personal fees from Philips and RESMED, grants from Vital Air, VIVISOL and Goedegebuure, and personal fees from Synapse and Bresotec, all outside the submitted work.

Figures

Figure 1
Figure 1
Figure 1Consort diagram of the RECONSIDER trial. One patient that was non-compliant and stopped his NIV was followed for outcome measurements (shown in italic). FEV1, Forced Expiratory Volume in 1 second; NIV, non-invasive ventilation.
Figure 2
Figure 2
Arterial carbon dioxide pressure (PaCO2) at daytime during spontaneous breathing without NIV. Shown are individual patient values of the home and hospital groups and the mean value (home: ∆; hospital: □). 3 mo, 3 months after NIV initiation; 6 mo, 6 months after NIV initiation; NIV, non-invasive ventilation.
Figure 3
Figure 3
Change in HRQoL per group. Data are shown as mean±SD. For the CCQ, a decrease means an improvement in HRQoL (Minimal Clinical Important Difference −0.4 points). For the SRI, an increase means an improvement in HRQoL. HRQoL: health-related quality of life; CCQ: Clinical COPD Questionnaire; SRI: Severe Respiratory Insufficiency questionnaire, with its domains: RC: respiratory complaints; PF: physical functioning, AS: attendant symptoms and sleep; SR: social relationships; AX: anxiety; WB: psychological well-being; SF: social functioning, SS: summary score.
Figure 4
Figure 4
Costs (€) of NIV initiation hospital versus at home. Represented as median costs (€). Material: costs of the ventilator, telemedicine material and material/device for transcutaneous measurements; travel km: costs for travel kilometres of the specialised respiratory nurse; travel time: costs for travel time to the patients of the specialised respiratory nurse; telephone contact: costs for the time spend by the respiratory nurse to have telephone contact with the patients; nurse time: costs of the time spend by the specialised nurse directly with the patient; ward days: costs of the ward days. *p< 0.001. NIV, non-invasive ventilation.
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