• Respiratory medicine · Jul 2014

    Randomized Controlled Trial Multicenter Study Comparative Study

    Ambulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment.

    • Mercedes Pallero, Carme Puy, Rosa Güell, Caridad Pontes, Sergi Martí, Ferran Torres, Antonio Antón, and Xavier Muñoz.
    • Respiratory Medicine Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain; CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Departament de Medicina, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
    • Respir Med. 2014 Jul 1;108(7):1014-22.

    BackgroundHome mechanical ventilation is usually initiated in hospital. However, cost-effectiveness of inpatient set up has never been compared to outpatient adaptation in a randomized design. A Prospective, multicenter, non-inferiority trial was conducted comparing the effectiveness of adaptation to noninvasive mechanical ventilation (NIMV) performed in the ambulatory or hospital setting in patients with chronic respiratory failure secondary to restrictive thoracic disease, obesity-hypoventilation syndrome or neuromuscular disease.MethodsThe study included 53 candidates for NIMV, randomized to ambulatory adaptation (AA) (n = 27) or hospital adaptation (HA) (n = 26). The patients' characteristics were recorded before establishing ventilation and at 1 and 6 months after. The main outcome variable was PaCO2 decrease at 6 months following initiation of NIMV. The direct costs of the two interventions were compared.ResultsBefore starting NIMV, PaCO2 was 50.4 ± 6.8 mmHg in the AA group and 50.3 ± 5.7 mmHg in the HA group. At 6 months of NIMV use, a significant improvement in PaCO2 relative to baseline was found in both groups: mean (95% CI) PaCO2 decrease was 4.9 (2.3; 7.4) mmHg in AA and 3.3 (1.4; 5.1) mmHg in HA. The direct calculated cost was 1500 euros per patient in AA and 2692 euros per patient in HA.ConclusionsAdaptation to NIMV in the ambulatory setting is not inferior to hospital adaptation in terms of therapeutic equivalence in stable patients with chronic respiratory failure secondary to restrictive thoracic disease, obesity-hypoventilation syndrome or neuromuscular disease. Outpatient adaptation may represent a cost saving for the healthcare system.Clinical TrialIdentifier number NCT00698958 at www.clinicaltrials.gov.Copyright © 2014 Elsevier Ltd. All rights reserved.

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