UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040216 |
|---|---|
| Receipt number | R000045849 |
| Scientific Title | HIGH FLOW NASAL CANNULA IN PEDIATRIC PATIENTS AFTER CARDIOTHORACIC SURGERY:A RANDOMIZED CONTROLLED TRIAL |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/12/21 10:53:56 |
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Basic information
Public title
HIGH FLOW NASAL CANNULA IN PEDIATRIC PATIENTS AFTER CARDIOTHORACIC SURGERY:A RANDOMIZED CONTROLLED TRIAL
Acronym
OSACA CATS TRIAL
Scientific Title
HIGH FLOW NASAL CANNULA IN PEDIATRIC PATIENTS AFTER CARDIOTHORACIC SURGERY:A RANDOMIZED CONTROLLED TRIAL
Scientific Title:Acronym
OSACA CATS TRIAL
Region
| Japan |
Condition
Condition
pediatric patients after cardiothoracic surgery
Classification by specialty
| Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This multicenter RCT involving pediatric patients after cardiothoracic surgery will be conducted to determine whether high-flow nasal cannula,compared with conventional oxygen therapy,after extubation can reduce the rate of"escalation of care due to treatment failure"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the rate of"escalation of care due to treatment failure" within 72 hours after extubation
Key secondary outcomes
1non event rate within 72 hours after extubation2peripheral oxygen saturation3fractional inspired oxygen4potential of hydrogen5partial pressure of carbon dioxide in arterial blood6respiratory rate7lactate8heart rate9mean blood pressure10catecholamine score11sedative dose12chest x ray score13Inhaled oxygen flow rate14criteria of treatment failure15details of escalation of care16treatment outcome of the patients who have been diagnosed as treatment failure at the time of 72 hours after extubation17the rate of reintubation at the time of 72 hours after extubation18ICU days19hospital days20adverse events21prespecified sub group analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
high flow nasal cannula
Interventions/Control_2
conventional oxygen therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 2 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)pediatric patients younger than two years old after cardiothoracic surgery
2)pediatric patients who have been ventilated for more than 12 hours after surgery
Key exclusion criteria
1)patients with tracheostomy
2)patients with DNR(do not resuscitate)
3)patients who have be treated by noninvasive positive pressure ventilation or high flow nasal cannula before surgery
4)patients who undergo unplanned extubation
5)patients who have withdrawn consent from their legal guardian
6)patients who don't need oxygen therapy
7)patients who are planned to receive treatment with noninvasive positive pressure ventilation after extubation
8)patients who are planned to inhale nitric oxide(NO) after extubation
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6820-5820
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6820-5820
Homepage URL
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Medicine,Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka Universty Hospital
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
Tel
06-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院(大阪府)、大阪母子医療センター(大阪府)、兵庫県立こども病院(兵庫県)、大阪市立総合医療センター(大阪府)、あいち小児保健医療総合センター(愛知県)、国立成育医療研究センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Progress is delayed.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045849
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