PMID- 37068905
OWN - NLM
STAT- MEDLINE
DCOM- 20230419
LR  - 20230423
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 13
IP  - 4
DP  - 2023 Apr 17
TI  - Epidemiology of adverse events attributed to airway management in paediatric 
      anaesthesia: protocol for the prospective, multicentre, registry-based, 
      cross-sectional Japan Pediatric Difficult Airway in Anesthesia study (J-PEDIA).
PG  - e067554
LID - 10.1136/bmjopen-2022-067554 [doi]
LID - e067554
AB  - INTRODUCTION: Failure to secure an airway during general anaesthesia is a major 
      cause of adverse events (AEs) in children. The safety of paediatric anaesthesia 
      may be improved by identifying the incidence of AEs and their attributed risk 
      factors. The aim of the current study is to obtain real-world data on the 
      incidence of adverse peri-intubation events and assess their association with 
      patient characteristics (including the prevalence of difficult airway features) 
      and choice of anaesthesia management. These data can be used to develop a 
      targeted education programme for anaesthesia providers towards quality 
      improvement activities. METHODS AND ANALYSIS: This prospective, multicentre, 
      registry-based, cross-sectional study will be conducted in four tertiary care 
      hospitals in Japan from June 2022 to May 2025. Children <18 years of age 
      undergoing surgical and/or diagnostic test procedures under general anaesthesia 
      or sedation by anaesthesiologists will be enrolled in this study. Data on patient 
      characteristics, discipline of anaesthesia providers and methodology of airway 
      management will be collected through a standardised verification system. The 
      exposure of interest is the presence of difficult airway features defined based 
      on the craniofacial appearance. The primary and secondary endpoints are all AEs 
      associated with airway management and reduced peripheral capillary oxygen 
      saturation values. Potential confounders are related to the failure to secure the 
      airway and variations in the anaesthesia providers' levels, adjusted using 
      hierarchical multivariable regression models with mixed effects. The sample size 
      was calculated to be approximately 16 000 assuming a 99% probability of obtaining 
      a 95% Wilson CI with+/-0.3% of the half-width for the 2.0% of the incidence of 
      critical AEs. ETHICS AND DISSEMINATION: The study protocol was approved by the 
      Institutional Review Board at Aichi Children's Health and Medical Center 
      (2021051). The results will be reported in a peer-reviewed journal and a relevant 
      academic conference. TRIAL REGISTRATION NUMBER: UMIN000047351.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Kojima, Taiki
AU  - Kojima T
AD  - Department of Anesthesiology, Aichi Children's Health and Medical Center, Obu, 
      Aichi, Japan daiki_kojima@sk00106.achmc.pref.aichi.jp.
AD  - Division of Comprehensive Pediatric Medicine, Nagoya University Graduate School 
      of Medicine, Nagoya, Aichi, Japan.
FAU - Yamauchi, Yusuke
AU  - Yamauchi Y
AD  - Department of Anesthesiology, Aichi Children's Health and Medical Center, Obu, 
      Aichi, Japan.
FAU - Watanabe, Fumio
AU  - Watanabe F
AD  - Department of Anesthesiology, Aichi Children's Health and Medical Center, Obu, 
      Aichi, Japan.
FAU - Ichiyanagi, Shogo
AU  - Ichiyanagi S
AD  - Department of Anesthesiology, Aichi Children's Health and Medical Center, Obu, 
      Aichi, Japan.
FAU - Kobayashi, Yasuma
AU  - Kobayashi Y
AD  - Children's Heart Center, Saitama Children's Medical Center, Saitama, Japan.
FAU - Kaiho, Yu
AU  - Kaiho Y
AD  - Department of Anesthesiology, Tohoku University Hospital, Sendai, Japan.
FAU - Kasuya, Shugo
AU  - Kasuya S
AD  - Department of Critical Care and Anesthesiology, National Center for Child Health 
      and Development, Setagaya-ku, Japan.
FAU - Urayama, Kevin Y
AU  - Urayama KY
AD  - St Luke's International University, Chuo-ku, Tokyo, Japan.
FAU - Kuratani, Norifumi
AU  - Kuratani N
AD  - Anesthesiology, Saitama Children's Medical Center, Saitama, Japan.
FAU - Suzuki, Yasuyuki
AU  - Suzuki Y
AD  - Department of Critical Care and Anesthesiology, National Center for Child Health 
      and Development, Setagaya-ku, Japan.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230417
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Child
MH  - Humans
MH  - Cross-Sectional Studies
MH  - Prospective Studies
MH  - Japan/epidemiology
MH  - *Airway Management/adverse effects/methods
MH  - *Anesthesia, General/adverse effects/methods
MH  - Registries
MH  - Multicenter Studies as Topic
PMC - PMC10111891
OTO - NOTNLM
OT  - Adverse events
OT  - Paediatric anaesthesia
OT  - Paediatric intensive & critical care
COIS- Competing interests: None declared.
EDAT- 2023/04/18 06:00
MHDA- 2023/04/19 06:42
PMCR- 2023/04/17
CRDT- 2023/04/17 21:03
PHST- 2023/04/19 06:42 [medline]
PHST- 2023/04/17 21:03 [entrez]
PHST- 2023/04/18 06:00 [pubmed]
PHST- 2023/04/17 00:00 [pmc-release]
AID - bmjopen-2022-067554 [pii]
AID - 10.1136/bmjopen-2022-067554 [doi]
PST - epublish
SO  - BMJ Open. 2023 Apr 17;13(4):e067554. doi: 10.1136/bmjopen-2022-067554.