Pediatric Patients After Cardiothoracic Surgery
Conditions
Keywords
high flow nasal cannula, conventional oxygen therapy, treatment failure after extubation
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 ofescalation 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.
Interventions
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
DEVICElow 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
Sponsors
Osaka Women's and Children's Hospital
Hyogo Prefectural Kobe Children's Hospital
Osaka City General Hospital
Aichi Children's Health and Medical Center
National Center for Child Health and Development
Osaka University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blind .Participants and their legal representatives are blinded.
Intervention model description
control group:conventional oxygen therapy interventional group:high flow nasal cannula
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate ofescalation of care due to treatment failure within 72 hours after extubation | Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peripheral oxygen saturation | 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. | oxygen saturation (SpO2) |
| arterial blood gas | 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. | potential of hydrogen (pH) |
| vital sign | 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. | respiratory rate |
| fractional inspired oxygen | 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 (FiO2) |
| Catecholamine score | 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 | 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 | Outcome is assessed within 24 hours before extubation,within 24 hours after extubation. | 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. |
| Oxygen flow rate | Outcome is assessed at the time as follows;1 hour,12 hours,24 hours,48 hours and 72 hours after extubation. | Inhaled oxygen flow rate |
| non event rate within 72 hours after extubation | Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed 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. |
| Details ofescalation of care | Outcome measure is assessed within 72 hours after extubation. | 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). |
| at the time of 72 hours after extubation, treatment outcome of the patients who have been diagnosed as treatment failure | Outcome measure is assessed at the time of 72 hours after extubation | 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. |
| 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 | Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation. | Primary outcome is assessed by sub group analysis as follows; age(less than 30 days,more than 31 days). |
| criteria of treatment failure | Outcome measure is assessed within 72 hours after extubation. | 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. |
Countries
Japan
Contacts
Primary ContactTakeshi Yoshida, MDPhD
Outcome results
None listed