High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery (OSACA CATS)

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

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".

Study Overview

• Status: Recruiting
• Conditions: Pediatric Patients After Cardiothoracic Surgery
• Intervention / Treatment: Device: high flow nasal cannula therapy; Device: low flow nasal cannula therapy

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 Type: Interventional
• Enrollment (Anticipated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Takeshi Yoshida, MDPhD; Phone Number: +81668795820; Email: takeshiyoshida@hp-icu.med.osaka-u.ac.jp

Study Locations

• Japan
  • Osaka, Japan
    • Recruiting
    • Department of Anesthesiology and Intensive Care Medicine, Osaka University
    • Contact: Takeshi Yoshida, MDPhD; Phone Number: +81668795820; Email: takeshiyoshida@hp-icu.med.osaka-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high flow nasal nasal cannula; Patients allocated for this arm are received high flow nasal cannula therapy after extubation.	Device: 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; Other Names: high flow nasal cannula oxygen therapy
Active Comparator: low flow nasal cannula; 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; Other Names: conventional oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the rate of"escalation 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 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).	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.	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.

Collaborators and Investigators

• Sponsor: Osaka University
• Collaborators: Osaka City General Hospital; Osaka Women's and Children's Hospital; Hyogo Prefectural Kobe Children's Hospital; Aichi Children's Health and Medical Center; National Center for Child Health and Development
• Investigators: Study Chair: Takeshi Yoshida, MDPhD, Department of Anesthesiology and Intensive Care Medicine, Osaka University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: high flow nasal cannula; conventional oxygen therapy; treatment failure after extubation
• Other Study ID Numbers: OSACA CATS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No