Clinical trial NCT04451057: High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery
Official title: High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Patients After Cardiothoracic Surgery
Keywords: high flow nasal cannula
conventional oxygen therapy
treatment failure after extubation
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Osaka Women's and Children's Hospital
name: Hyogo Prefectural Kobe Children's Hospital
name: Osaka City General Hospital
name: Aichi Children's Health and Medical Center
name: National Center for Child Health and Development
First posted: 2020-06-30
Enrollment: 286
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group:conventional oxygen therapy interventional group:high flow nasal cannula
Primary purpose: TREATMENT

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".

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.

Eligibility criteria: 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

Primary outcomes:
measure: the rate of"escalation of care due to treatment failure" within 72 hours after extubation
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
Secondary outcomes:
measure: non event rate within 72 hours after extubation
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
measure: peripheral oxygen saturation
timeFrame: 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.
measure: arterial blood gas
timeFrame: 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.
measure: arterial blood gas
timeFrame: 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.
measure: arterial blood gas
timeFrame: 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.
measure: vital sign
timeFrame: 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.
measure: vital sign
timeFrame: 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.
measure: vital sign
timeFrame: 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.
measure: fractional inspired oxygen
timeFrame: 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.
measure: Catecholamine score
timeFrame: 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.
measure: sedative dose
timeFrame: 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.
measure: Chest x-ray score
timeFrame: Outcome is assessed within 24 hours before extubation,within 24 hours after extubation.
measure: Oxygen flow rate
timeFrame: Outcome is assessed at the time as follows;1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.
measure: criteria of "treatment failure"
timeFrame: Outcome measure is assessed within 72 hours after extubation.
measure: Details of"escalation of care"
timeFrame: Outcome measure is assessed within 72 hours after extubation.
measure: at the time of 72 hours after extubation, treatment outcome of the patients who have been diagnosed as "treatment failure"
timeFrame: Outcome measure is assessed at the time of 72 hours after extubation
measure: the rate of reintubation at the time of 72 hours after extubation
timeFrame: Outcome measure is assessed at the time of 72 hours after extubation
measure: the length of ICU stay
timeFrame: through study completion,an average of 1 month
measure: the length of hospital stay
timeFrame: Outcome measure is assessed when the patients is discharged from the hospital or the time of six months after extubation.
measure: adverse events
timeFrame: through study completion,an average of 1 month
measure: prespecified sub group analysis
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
measure: prespecified sub group analysis
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
measure: prespecified sub group analysis
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
measure: prespecified sub group analysis
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
measure: prespecified sub group analysis
timeFrame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Department of Anesthesiology and Intensive Care Medicine, Osaka University
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Osaka University
name: Takeshi Yoshida, MDPhD
role: STUDY_CHAIR
References: