High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery

Study Overview
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Brief Summary
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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 ofescalation of care due to treatment failure.

Detailed Description
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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.

Official Title
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High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery:A Randomized Controlled Trial

Conditions
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Pediatric Patients After Cardiothoracic Surgery

Intervention / Treatment
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* Device: high flow nasal cannula therapy
* Device: low flow nasal cannula therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients younger than two years old after cardiothoracic surgery pediatric patients who have been ventilated for more than 12 hours after surgery Exclusion Criteria: patients with tracheostomy 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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control group:conventional oxygen therapy interventional group:high flow nasal cannula
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high flow nasal nasal cannula<br>Patients allocated for this arm are received high flow nasal cannula therapy after extubation. | Device: high flow nasal cannula therapy<br>* Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization<br>* Other names: high flow nasal cannula oxygen therapy;|
| Active Comparator: low flow nasal cannula<br>Patients allocated for this arm are received conventional oxygen therapy after extubation. | Device: low flow nasal cannula therapy<br>* Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization<br>* Other names: conventional oxygen therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate ofescalation of care due to treatment failure within 72 hours after extubation |  | Final outcome measure is assessed when 380 patients have been recruited.Outcome measure is assessed within 72 hours after extubation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Final outcome measure is assessed when 380 patients have been recruited.Outcome measure is assessed within 72 hours after extubation. | 
| peripheral oxygen saturation | oxygen saturation (SpO2) | Final outcome measure is assessed when 380 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) | Final outcome measure is assessed when 380 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) | Final outcome measure is assessed when 380 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 | Final outcome measure is assessed when 380 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 | Final outcome measure is assessed when 380 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 | Final outcome measure is assessed when 380 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 | Final outcome measure is assessed when 380 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) | Final outcome measure is assessed when 380 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 |  | Final outcome measure is assessed when 380 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 |  | 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. | Outcome is assessed within 24 hours before extubation,within 24 hours after extubation. | 
| Oxygen flow rate | Inhaled oxygen flow rate | 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. | Outcome measure is assessed within 72 hours after extubation. | 
| Details ofescalation 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). | 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 moreescalation 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 moreescalation of care by receiving NPPV therapy,5 They have received mechanical ventilation therapy despite receiving NPPV therapy. | Outcome measure is assessed at the time of 72 hours after extubation | 
| the rate of reintubation at the time of 72 hours after extubation |  | Outcome measure is assessed at the time of 72 hours after extubation | 
| the length of ICU stay |  | through study completion,an average of 1 month | 
| the length of hospital stay |  | Outcome measure is assessed when the patients is discharged from the hospital or the time of six months after extubation. | 
| adverse events |  | 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). | Final outcome measure is assessed when 380 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. | Final outcome measure is assessed when 380 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) | Final outcome measure is assessed when 380 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. | Final outcome measure is assessed when 380 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). | Final outcome measure is assessed when 380 patients have been recruited.Outcome measure is assessed within 72 hours after extubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high flow nasal cannula, conventional oxygen therapy, treatment failure after extubation