Mercedes Pallero1, Carme Puy2, Rosa Güell2, Caridad Pontes3, Sergi Martí4, Ferran Torres3, Antonio Antón2, Xavier Muñoz5. 1. 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. 2. Respiratory Medicine Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 3. Biostatistics and Data Management Platform, IDIBAPS, Hospital Clínic, Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain. 4. 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. Electronic address: pneumo@vhebron.net. 5. 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; Department de Biologia Celular, Fisiologia, Inmunologia, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
Abstract
BACKGROUND:Home 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. METHODS: The 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. RESULTS: Before 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. CONCLUSIONS: Adaptation 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 TRIAL: Identifier number NCT00698958 at www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: Home 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. METHODS: The 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. RESULTS: Before 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. CONCLUSIONS: Adaptation 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 TRIAL: Identifier number NCT00698958 at www.clinicaltrials.gov.
Authors: Mitali Stevens; Apeksha V Shenoy; Sibyl H Munson; Halit O Yapici; Boye L A Gricar; Xuan Zhang; Andrew D Shaw Journal: PLoS One Date: 2019-12-19 Impact factor: 3.240
Authors: Marieke L Duiverman; Judith M Vonk; Gerrie Bladder; Joost P van Melle; Jellie Nieuwenhuis; Anda Hazenberg; Huib A M Kerstjens; Job F M van Boven; Peter J Wijkstra Journal: Thorax Date: 2019-09-04 Impact factor: 9.139