Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

This study has been completed.

Sponsor:

Collaborators:

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

First received: June 13, 2008

Last updated: June 16, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 13, 2008
Last Updated Date	June 16, 2008
Start Date ^ICMJE	June 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2008)	Change in PaCO2 from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Chronic Respiratory Failure
Intervention ^ICMJE	Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days Ambulatory 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
Study Arm (s)	Active Comparator: 1 Hospital based adaptation to non- invasive mechanical ventilation for 7 days Intervention: Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days Experimental: 2 Ambulatory adaptation to non- invasive mechanical ventilation for 7 days Intervention: Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Publications *	Pallero M, Puy C, Güell R, Pontes C, Martí S, Torres F, Antón A, Muñoz 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	52
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00698958
Other Study ID Numbers ^ICMJE	NEUMO/2002/01
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Xavier Muñoz Gall, Hospitals Vall d'Hebron
Study Sponsor ^ICMJE	Hospital Clinic of Barcelona
Collaborators ^ICMJE	Hospital Universitari Vall d'Hebron Research Institute Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital Clinic of Barcelona
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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