High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery
NCT ID: NCT04451057
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
286 participants
INTERVENTIONAL
2020-08-11
2024-06-30
Brief Summary
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Therefore because of its physiological benefits, it has been reported that HFNC can reduce "treatment failure" after extubation in pediatric patients like preterm babies,or infants who suffer from bronchitis.
However there is no evidence showing that HFNC can reduce "treatment failure" after extubation in pediatric patients after cardiothoracic surgery.
This multi-center randomized controlled trial (RCT) involving pediatric patients after cardiothoracic surgery will be conducted to determine whether HFNC,compared with conventional oxygen therapy,after extubation can reduce the rate of"escalation of care due to treatment failure".
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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high flow nasal nasal cannula
Patients allocated for this arm are received high flow nasal cannula therapy after extubation.
high flow nasal cannula therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
low flow nasal cannula
Patients allocated for this arm are received conventional oxygen therapy after extubation.
low flow nasal cannula therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
Interventions
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high flow nasal cannula therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
low flow nasal cannula therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pediatric patients who have been ventilated for more than 12 hours after surgery
Exclusion Criteria
* patients with do-not-resuscitate (DNR)
* patients who have be treated by noninvasive positive pressure ventilation or high flow nasal cannula before surgery
* patients who undergo unplanned extubation
* patients who have withdrawn consent from their legal guardian
* patients who don't need oxygen therapy
* patients who are planned to receive treatment with noninvasive positive pressure ventilation after extubation
* patients who are planned to inhale nitric oxide(NO) after extubation
2 Years
ALL
No
Sponsors
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Osaka Women's and Children's Hospital
UNKNOWN
Hyogo Prefectural Kobe Children's Hospital
OTHER
Osaka City General Hospital
OTHER
Aichi Children's Health and Medical Center
UNKNOWN
National Center for Child Health and Development
UNKNOWN
Osaka University
OTHER
Responsible Party
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Principal Investigators
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Takeshi Yoshida, MDPhD
Role: STUDY_CHAIR
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Locations
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Department of Anesthesiology and Intensive Care Medicine, Osaka University
Osaka, , Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OSACA CATS
Identifier Type: -
Identifier Source: org_study_id
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