Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT04451057
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2020-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery
Sponsor:
Osaka University
Organization:
Study Overview
Official Title:
High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery:A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSACA CATS
Brief Summary:
High flow nasal cannula(HFNC) ventilation can provide such effects as wash-out effect of the carbon dioxide inside the anatomical dead space,some level of continuous airway pressure and humidified oxygen gases.
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".
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".
Detailed Description:
The multi-center RCT will enroll 380 pediatric patients after cardiothoracic surgery from the Intensive Care Units (ICUs) in Japan.Informed consent will be obtained from the their parents or legally representatives.They will receive postoperative standard care in ICU and spontaneous breathing test(SBT).If SBT will be done successfully,they will be extubated.Just before extubation,they will be divided randomly into the intervention group or the control group.After randomization,they will be extubated.After extubation,the intervention group will receive HFNC therapy,while the control group will receive conventional oxygen therapy.The flow in the intervention group will surely be maintained to be high,while the flow in control group will surely be less than 2 liter/min.In both groups,outcome measure will be assessed within 72 hours after extubation,or during ICU stay.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: