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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00775710 |
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Date of registration:
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17/10/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure
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Scientific title:
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A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00775710 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Jacobo Sellares, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Acute hypercapnic respiratory failure.
- Use of NIV to treat respiratory failure.
- Persistence of hypercapnia after discontinuation of NIV
Exclusion Criteria:
- Home NIV
- Facial or cranial trauma or surgery,
- Recent gastric or esophageal surgery,
- Active upper gastrointestinal bleeding,
- Excessive amount of respiratory secretions,
- Tracheostomy
- Lack of cooperation
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypercapnic Respiratory Failure
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Intervention(s)
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Device: Nocturnal non-invasive ventilation
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Primary Outcome(s)
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New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation
[Time Frame: At the end of enrollment time]
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Secondary Outcome(s)
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Hospital and 6-month survival
[Time Frame: At the end of enrollment time]
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Incidence of long term dependency on non-invasive ventilation
[Time Frame: At the end of enrollment time]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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