Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Hospital Clinic of Barcelona Hospital Universitari Vall d'Hebron Research Institute Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
---|---|
Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00698958 |
A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.
Condition | Intervention | Phase |
---|---|---|
Chronic Respiratory Failure |
Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial to Compare the Effectiveness of Hospital or Ambulatory Approach for Adaptation to Non-Invasive Mechanical Ventilation in Patients With Chronic Respiratory Failure Secondary to Neuromuscular Diseases or Thoracic Cage Alterations |
Enrollment: | 52 |
Study Start Date: | June 2003 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
|
Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
|
2: Experimental
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
|
Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):
Exclusion Criteria:
Contraindications for mechanical ventilation:
Responsible Party: | Hospitals Vall d'Hebron ( Xavier Muñoz Gall ) |
Study ID Numbers: | NEUMO/2002/01 |
Study First Received: | June 13, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698958 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Respiratory insufficiency Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage |
Respiratory Insufficiency Respiratory Tract Diseases Hypercapnia |
Neuromuscular Diseases Respiration Disorders Neoplasm Metastasis |
Respiratory Insufficiency Respiratory Tract Diseases Neuromuscular Diseases Respiration Disorders Nervous System Diseases |