UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046328 |
|---|---|
| Receipt number | R000052803 |
| Scientific Title | Peri-anesthetic morbidity in children in Asia (PEACH in Asia) study: a prospective multinational multicenter observational study to investigate epidemiology of severe critical events in pediatric anesthesia in Asia |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2024/09/12 12:43:10 |
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Basic information
Public title
Peri-anesthetic morbidity in children in Asia (PEACH in Asia) study: a multinational multicenter observational study to investigate epidemiology of severe critical events in pediatric anesthesia in Asia
Acronym
PEACH in Asia study
Scientific Title
Peri-anesthetic morbidity in children in Asia (PEACH in Asia) study: a prospective multinational multicenter observational study to investigate epidemiology of severe critical events in pediatric anesthesia in Asia
Scientific Title:Acronym
PEACH in Asia study
Region
| Japan | Asia(except Japan) |
Condition
Condition
children aged less than 16 years old who are scheduled for an elective, urgent or emergency diagnostic or surgical procedure under sedation or general anesthesia with or without regional analgesia
Classification by specialty
| Surgery in general | Pediatrics | Anesthesiology |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the incidence of severe critical events in children aged less than 16 years old undergoing anesthesia and sedation in Asia.
2. To describe the differences in pediatric anesthesia practice throughout Asia.
3. To study the potential impact of this variability on the occurrence of severe critical events
Basic objectives2
Others
Basic objectives -Others
1. To investigate the incidence of severe critical events in children aged less than 16 years old undergoing anesthesia and sedation in Asia.
2. To describe the differences in pediatric anesthesia practice throughout Asia.
3. To study the potential impact of this variability on the occurrence of severe critical events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the incidence of the following severe critical events defined as any incident occurring during and up to 60 minutes after anesthesia or sedation, requiring immediate intervention and that may lead to major disability and/or death: (1) laryngospasm, (2) bronchospasm, (3) pulmonary aspiration, (4) drug error, (5) anaphylaxis, (6) cardiovascular instability, (7) neurological damage, (8) peri-operative cardiac arrest, (9) post-operative stridor
Key secondary outcomes
1. To investigate the risk factors for the occurrence of severe critical events
2. To investigate the consequences of severe critical events defined as irreversible damage and mortality (time frame: in-hospital or up to 30 days)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | days-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: from birth to aged less than 16 years old
2. Children admitted for an inpatient or outpatient procedure under general anesthesia with or without regional analgesia or under regional anesthesia alone. This includes all kind of surgeries and procedures requiring anesthesia and analgesia to be performed such as central venous access, burn care, cast, etc.
3. Children admitted for a diagnostic procedure under sedation (performed by an anesthesiologist) or general anesthesia (such as endoscopy, radiology (CT-scan, MRI), cardiac catheterization and electrophysiology, PET-scan, radiotherapy, lumbar and bone marrow puncture, biopsies), diagnostic procedure under general anesthesia (such as endoscopy, radiology)
4. Children admitted for urgent or emergency procedure performed in- or out-of-hours
Key exclusion criteria
1. Children admitted directly from the intensive care units to the operating rooms
2. Anesthesia or sedation procedures in the neonatal or pediatric intensive care units
3. Age: Children aged 16 years old and over
Target sample size
10958
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Obara |
Organization
Tokyo Metropolitan Ohtsuka Hospital / Teikyo University
Division name
Department of Anesthesia / Graduate School of Public Health
Zip code
170-8476
Address
2-8-1, Minami-ohtsuka, Toshima-ku, Tokyo, 170-8476, Japan
TEL
+81-3-3941-3211
obara.souichirou.bv@teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Obara |
Organization
Tokyo Metropolitan Ohtsuka Hospital / Teikyo University
Division name
Department of Anesthesia / Graduate School of Public Health
Zip code
170-8476
Address
2-8-1, Minami-ohtsuka, Toshima-ku, Tokyo, 170-8476, Japan
TEL
+81-3-3941-3211
Homepage URL
peachinasia@gmail.com
Sponsor or person
Institute
Asian Society of Pediatric Anesthesiologists, Research Special Interest Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology in Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Ohtsuka Hospital
Address
2-8-1, Minami-ohtsuka, Toshima-ku, Tokyo, 170-8476, Japan
Tel
+81-3-3941-3211
soichoba1975@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 28 | 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
Results Delay Reason
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
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. The 2-week recruitment period will be chosen by each site commencing on 01 July 2022 (as planned). The last possible inclusion date will be decided by the study steering committee (the Asian Society of Pediatric Anesthesiologists, research committee) depending on the recruitment rate.
2. Participating institutions will be provided with data acquisition sheets that enable anonymous standardized recording of all patients' parameters, which will be used by the local institution to fill in the electronic case report form (eCRF).
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052803
