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


BACKGROUND
Identifier number NCT00698958 at www.clinicaltrials.gov.
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.
Mercedes
M
Pallero
Respiratory Medicine Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Carme
C
Puy
Respiratory Medicine Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Rosa
R
Güell
Biostatistics and Data Management Platform, IDIBAPS, Hospital Clínic, Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
Caridad
C
Pontes
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.
Sergi
S
Martí
Biostatistics and Data Management Platform, IDIBAPS, Hospital Clínic, Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
Ferran
F
Torres
Respiratory Medicine Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Antonio
A
Antón
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.
Xavier
X
Muñoz
D000223:Adaptation, Psychological; D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D002245:Carbon Dioxide / Q000097:blood; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D017048:Health Care Costs / Q000706:statistics & numerical data; D006302:Health Services Research / Q000379:methods; D018575:Home Care Services, Hospital-Based / Q000191:economics / Q000458:organization & administration*; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D063087:Noninvasive Ventilation / Q000191:economics* / Q000379:methods / Q000523:psychology; D010044:Outpatient Clinics, Hospital / Q000191:economics / Q000458:organization & administration; D010313:Partial Pressure; D011446:Prospective Studies; D012131:Respiratory Insufficiency / Q000191:economics / Q000523:psychology / Q000628:therapy*; D013030:Spain; D055815:Young Adult
D002245:Carbon Dioxide
Ambulatory adaptation; Chest wall disease; Neuromuscular disease; Noninvasive ventilation