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

Osaka University

Status: Enrolling

Conditions: Pediatric Patients After Cardiothoracic Surgery

Treatments: Device: low flow nasal cannula therapy; Device: high flow nasal cannula therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04451057

OSACA CATS

Details and patient eligibility

About

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".

Full 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.

Enrollment: 286 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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286 participants in 2 patient groups

high flow nasal nasal cannula

Experimental group

Description:

Patients allocated for this arm are received high flow nasal cannula therapy after extubation.

Treatment:

Device: high flow nasal cannula therapy

low flow nasal cannula

Active Comparator group

Description:

Patients allocated for this arm are received conventional oxygen therapy after extubation.

Treatment:

Device: low flow nasal cannula therapy