Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

This study has been completed.

First Received: June 13, 2008 Last Updated: June 16, 2008 History of Changes

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

Purpose

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

MedlinePlus related topics: Neuromuscular Disorders

U.S. FDA Resources

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

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Change in PaCO2 from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in PaCO2 from start of mechanical ventilation [ Designated as safety issue: No ]
6-minute walking test [ Designated as safety issue: No ]
Adaptation failure [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 75
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):
- PaCO2 > 45 mmHg
- Night time oxygen saturation < 88% at least for 5 consecutive minutes
- In neuromuscular diseases, PIM < 60 cmH2O or FVC < 50% of theoretical.
Stable disease.
Airway access through nasal mask.
Ability to provide written informed consent.
Ability to attend the visits

Exclusion Criteria:

Contraindications for mechanical ventilation:
- Patient with terminal disease or vegetative state
- Lack of motivation of the patient
- Lack of family or social support
- Patients clinically unstable
- Agitation or lack of co-operation
- Depression.
Patients with acute symptoms requiring hospital admission.
Need for airway access through tracheostomy, face mask or mouth piece.
Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.
Lack of understanding of the study procedures.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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

Keywords provided by Hospital Clinic of Barcelona:

Respiratory insufficiency
Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Hypercapnia

Neuromuscular Diseases
Respiration Disorders
Neoplasm Metastasis

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiratory Tract Diseases
Neuromuscular Diseases
Respiration Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 07, 2009