Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
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ClinicalTrials.gov Identifier: NCT00698958 |
Recruitment Status :
Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
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Sponsor:
Hospital Clinic of Barcelona
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
Tracking Information | |||
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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 |
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 |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Chronic Respiratory Failure | ||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
52 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Study Completion Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | Not Provided | ||
Responsible Party | Xavier Muñoz Gall, Hospitals Vall d'Hebron | ||
Study Sponsor ICMJE | Hospital Clinic of Barcelona | ||
Collaborators ICMJE |
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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 |