Pediatric Patients After Cardiothoracic SurgeryOSACA CATSNCT04451057
High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery
A study testing high flow nasal cannula therapy and low flow nasal cannula therapy in people with Pediatric Patients After Cardiothoracic Surgery, run by Osaka University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Pediatric Patients After Cardiothoracic Surgery
- What is being tested?
- high flow nasal cannula therapy and low flow nasal cannula therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteJapan
- Study dates
- 11 Aug 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients younger than two years old after cardiothoracic surgery
- pediatric patients who have been ventilated for more than 12 hours after surgery
Who cannot join
- 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- patients who have withdrawn consent from their legal guardian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 locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Osaka
Takeshi Yoshida, MDPhD, +81668795820, takeshiyoshida@hp-icu.med.osaka-u.ac.jp
About this study
Official title: 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.
Read more
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".
Read the 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.
- Being tested
- high flow nasal cannula therapy, low flow nasal cannula therapy
- Keywords
- high flow nasal cannula, conventional oxygen therapy, treatment failure after extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannula therapyDevice
Also called high flow nasal cannula oxygen therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
low flow nasal cannula therapyDevice
Also called conventional oxygen therapy
Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal nasal cannula | Experimental | Patients allocated for this arm are received high flow nasal cannula therapy after extubation. Receives: Device: high flow nasal cannula therapy |
| low flow nasal cannula | Active comparator | Patients allocated for this arm are received conventional oxygen therapy after extubation. Receives: Device: low flow nasal cannula therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of"escalation of care due to treatment failure" within 72 hours after extubation
Measured: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
Secondary outcomes (25)
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.
Measured: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
peripheral oxygen saturation
oxygen saturation (SpO2)
Measured: 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.
arterial blood gas
potential of hydrogen (pH)
Measured: 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.
arterial blood gas
partial pressure of carbon dioxide in arterial blood(PaCO2)
Measured: 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.
arterial blood gas
lactate
Measured: 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.
vital sign
respiratory rate
Measured: 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.
vital sign
heart rate
Measured: 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.
vital sign
mean blood pressure
Measured: 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
fractional inspired oxygen (FiO2)
Measured: 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.
Catecholamine score
Measured: 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
Measured: 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.
Measured: Outcome is assessed within 24 hours before extubation,within 24 hours after extubation.
Oxygen flow rate
Inhaled oxygen flow rate
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Outcome measure is assessed at the time of 72 hours after extubation
the rate of reintubation at the time of 72 hours after extubation
Measured: Outcome measure is assessed at the time of 72 hours after extubation
the length of ICU stay
Measured: through study completion,an average of 1 month
the length of hospital stay
Measured: Outcome measure is assessed when the patients is discharged from the hospital or the time of six months after extubation.
adverse events
Measured: 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).
Measured: Final outcome measure is assessed when total 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.
Measured: Final outcome measure is assessed when total 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)
Measured: Final outcome measure is assessed when total 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.
Measured: Final outcome measure is assessed when total 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).
Measured: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start11 Aug 2020
- Primary completion20 Feb 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients After Cardiothoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control group:conventional oxygen therapy interventional group:high flow nasal cannula
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Osaka Women's and Children's Hospital, Hyogo Prefectural Kobe Children's Hospital, Osaka City General Hospital, Aichi Children's Health and Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Takeshi Yoshida, MDPhD, Study chair, Department of Anesthesiology and Intensive Care Medicine, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451057
- Sponsor's protocol ID
- OSACA CATS
- Acronym
- OSACA CATS
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2020
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04451057
- Acronym / sponsor ID
- OSACA CATS / OSACA CATS
- Keywords
- high flow nasal cannula, conventional oxygen therapy, treatment failure after extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Osaka Women's and Children's Hospital, Hyogo Prefectural Kobe Children's Hospital, Osaka City General Hospital, Aichi Children's Health and Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- control group:conventional oxygen therapy interventional group:high flow nasal cannula
| Arm | Type | Receives |
|---|---|---|
| high flow nasal nasal cannula | Experimental | Device: high flow nasal cannula therapyPatients allocated for this arm are received high flow nasal cannula therapy after extubation. |
| low flow nasal cannula | Active comparator | Device: low flow nasal cannula therapyPatients allocated for this arm are received conventional oxygen therapy after extubation. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric patients younger than two years old after cardiothoracic surgery
- pediatric patients who have been ventilated for more than 12 hours after surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal cannula therapyAlso: high flow nasal cannula oxygen therapyOnce extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization | Device | high flow nasal nasal cannula |
| low flow nasal cannula therapyAlso: conventional oxygen therapyOnce extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization | Device | low flow nasal cannula |
Primary outcome
the rate of"escalation of care due to treatment failure" within 72 hours after extubation
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
25 secondary outcomes
non event rate within 72 hours after extubation
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
peripheral oxygen saturation
Time frame: 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.
arterial blood gas
Time frame: 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.
arterial blood gas
Time frame: 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.
arterial blood gas
Time frame: 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.
vital sign
Time frame: 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.
vital sign
Time frame: 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.
vital sign
Time frame: 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
Time frame: 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.
Catecholamine score
Time frame: 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
Time frame: 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
Time frame: Outcome is assessed within 24 hours before extubation,within 24 hours after extubation.
Oxygen flow rate
Time frame: 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"
Time frame: Outcome measure is assessed within 72 hours after extubation.
Details of"escalation of care"
Time frame: 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"
Time frame: Outcome measure is assessed at the time of 72 hours after extubation
the rate of reintubation at the time of 72 hours after extubation
Time frame: Outcome measure is assessed at the time of 72 hours after extubation
the length of ICU stay
Time frame: through study completion,an average of 1 month
the length of hospital stay
Time frame: Outcome measure is assessed when the patients is discharged from the hospital or the time of six months after extubation.
adverse events
Time frame: through study completion,an average of 1 month
prespecified sub group analysis
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
prespecified sub group analysis
Time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Yoshida, MDPhD study chair
Department of Anesthesiology and Intensive Care Medicine, Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula therapy and low flow nasal cannula therapy in people with Pediatric Patients After Cardiothoracic Surgery, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takeshi Yoshida, MDPhD (+81668795820, takeshiyoshida@hp-icu.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of"escalation of care due to treatment failure" within 72 hours after extubation (time frame: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.