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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03505814 |
Date of registration:
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03/04/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit
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Scientific title:
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Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit |
Date of first enrolment:
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March 1, 2017 |
Target sample size:
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126 |
Recruitment status: |
Unknown status |
URL:
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https://clinicaltrials.gov/show/NCT03505814 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Benkhalifa Sonia, Pr |
Address:
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Telephone:
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0021698360939 |
Email:
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benkhalifa_sonia@yahoo.fr |
Affiliation:
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Name:
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Ben Khalifa Sonia, Pr |
Address:
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Telephone:
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0021698360939 |
Email:
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benkhalifa_sonia@yahoo.fr |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- need for mechanical ventilation
- tracheal intubation
- surgical intensive care admission
- availability of extubation criteria
Exclusion Criteria:
- prior extubation and mechanical ventilation to the actual episode
- weaning failure due to neurological status
Age minimum:
N/A
Age maximum:
45 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Weaning Failure
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Intervention(s)
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Device: Conventional oxygen therapy
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Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)
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Primary Outcome(s)
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reintubation rate
[Time Frame: 72 hours following prior weaning and extubation]
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Secondary Outcome(s)
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heart rate
[Time Frame: 72 hours following prior weaning and extubation]
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respiratory rate
[Time Frame: 72 hours following prior weaning and extubation]
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incidence of post-extubation respiratory failure
[Time Frame: 72 hours following prior weaning and extubation]
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SpO2/FiO2
[Time Frame: 72 hours following prior weaning and extubation]
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time to reintubate
[Time Frame: 72 hours following prior weaning and extubation]
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blood pressure
[Time Frame: 72 hours following prior weaning and extubation]
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weaning time from oxygen.
[Time Frame: 72 hours following prior weaning and extubation]
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Secondary ID(s)
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HEBechirHamza
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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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