An interventional study of high flow nasal cannula therapy and low flow nasal cannula therapy in Pediatric Patients After Cardiothoracic Surgery, sponsored by Osaka University. Recruiting at 1 site in Japan. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Osaka University · Not applicable, Interventional, and Treatment
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".
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.
Osaka University is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients allocated for this arm are received high flow nasal cannula therapy after extubation.
Device: high flow nasal cannula therapy
Patients allocated for this arm are received conventional oxygen therapy after extubation.
Device: 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
Also known as: high flow nasal cannula oxygen therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
Also known as: conventional oxygen therapy
the rate of"escalation of care due to treatment failure" within 72 hours after extubation
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
non event rate within 72 hours after extubation
The event is defined as "escalation of care due to treatment failure "after extubation.Non event is defined as other than this event.
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
peripheral oxygen saturation
oxygen saturation (SpO2)
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
arterial blood gas
potential of hydrogen (pH)
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
arterial blood gas
partial pressure of carbon dioxide in arterial blood(PaCO2)
Time frame: Final outcome measure is assessed when patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
arterial blood gas
lactate
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
vital sign
respiratory rate
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
vital sign
heart rate
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
vital sign
mean blood pressure
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
fractional inspired oxygen
fractional inspired oxygen (FiO2)
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
Catecholamine score
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
sedative dose
Time frame: Outcome is assessed like as follows;total dose from 6 hours before extubation to extubation,total dose from 18 hours to 24 hours after extubation,total dose from 42 hours to 48 hours after extubation,total dose from 66 hours to 72 hours after extubation.
Chest x-ray score
The presence of atelectasis is expressed by a 5 point score:clear lung fields 0,plate-like atelectasis or slight infiltration 1,partial atelectasis 2,lobar atelectasis 3,bilateral lobar atelectasis 4.
Time frame: Outcome is assessed within 24 hours before extubation,within 24 hours after extubation.
Oxygen flow rate
Inhaled oxygen flow rate
Time frame: Outcome is assessed at the time as follows;1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
criteria of "treatment failure"
This criteria of "treatment failure" is defined as follows; 1 tachypnea,2 hypercapnia,3 reduced oxygen saturation,4 tachycardia,5 clinical symptoms suggesting respiratory distress, 6 life threatening signs,7 other clinical concerns or reasons.
Time frame: Outcome measure is assessed within 72 hours after extubation.
Details of"escalation of care"
The details of "escalation of care" are defined as follows;"escalation of care" is defined as noninvasive positive pressure ventilation (NPPV) therapy or mechanical ventilation therapy ,if patients have been allocated to intervention group ( group for HFNC therapy ).On the other hand, " escalation of care" is defined as HFNC therapy,NPPV therapy,or mechanical ventilation therapy, if patients have been allocated to control group ( group for conventional oxygen therapy).
Time frame: Outcome measure is assessed within 72 hours after extubation.
at the time of 72 hours after extubation, treatment outcome of the patients who have been diagnosed as "treatment failure"
This treatment outcome of these patients is defined as follows;1 They haven't receive more"escalation of care" by receiving HFNC therapy,2 They have received noninvasive positive pressure ventilation (NPPV) therapy despite receiving HFNC therapy,3 They have received mechanical ventilation therapy despite receiving HFNC therapy,4They haven't receive more"escalation of care" by receiving NPPV therapy,5 They have received mechanical ventilation therapy despite receiving NPPV therapy.
Time frame: Outcome measure is assessed at the time of 72 hours after extubation
the rate of reintubation at the time of 72 hours after extubation
Time frame: Outcome measure is assessed at the time of 72 hours after extubation
the length of ICU stay
Time frame: through study completion,an average of 1 month
the length of hospital stay
Time frame: Outcome measure is assessed when the patients is discharged from the hospital or the time of six months after extubation.
adverse events
Time frame: through study completion,an average of 1 month
prespecified sub group analysis
Primary outcome is assessed by sub group analysis as follows; age(less than 30 days,more than 31 days).
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Primary outcome is assessed by sub group analysis as follows;chromosomal abnormality.
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Primary outcome is assessed by sub group analysis as follows;RACHES-1 score. hours,more than 6 hours)
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Primary outcome is assessed by sub group analysis as follows;postoperative cyanosis.
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Primary outcome is assessed by sub group analysis as follows; operation time(less than 6 hours,more than 6 hours).
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
Plan to share: No
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Osaka University