Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Tracking Information
First Submitted Date ICMJE	June 13, 2008
First Posted Date ICMJE	June 17, 2008
Last Update Posted Date	June 17, 2008
Study 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 ]
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; 6-minute walking test; Adaptation failure
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; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: June 16, 2008)	52
Original Actual Enrollment ICMJE	Same as current
Study 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.
Sex/Gender	Sexes Eligible for Study: All
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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