Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
NCT ID: NCT00698958
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2003-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
2
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Interventions
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Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Stable disease.
4. Airway access through nasal mask.
5. Ability to provide written informed consent.
6. Ability to attend the visits
Exclusion Criteria
* 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.
2. Patients with acute symptoms requiring hospital admission.
3. Need for airway access through tracheostomy, face mask or mouth piece.
4. Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
5. 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.
6. Lack of understanding of the study procedures.
18 Years
75 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Hospitals Vall d'Hebron
References
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Pallero M, Puy C, Guell R, Pontes C, Marti S, Torres F, Anton A, Munoz X. Ambulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment. Respir Med. 2014 Jul;108(7):1014-22. doi: 10.1016/j.rmed.2014.04.016. Epub 2014 May 2.
Other Identifiers
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NEUMO/2002/01
Identifier Type: -
Identifier Source: org_study_id