Postoperative Atelectasis in Pediatric Patients With Prone Position
1 other identifier
interventional
74
1 country
1
Brief Summary
This study evaluates the incidence of postoperative atelectasis after general anesthesia with prone position using lung ultrasound in children age \< 3 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2018
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedApril 16, 2020
April 1, 2020
1.3 years
March 26, 2018
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of pre-extubation atelectasis
Incidence of pre-extubation atelectasis accessed by lung ultrasound
postoperative 10 minutes
Secondary Outcomes (4)
Incidence of intraoperative atelectasis after intubation
intraoperative
Incidence of intraoperative atelectasis after position change to prone
intraoperative
Incidence of intraoperative and postoperative (within 12hr) desaturation
intraoperative and postoperative (within 12hr)
Incidence of intraoperative hypotension
intraoperative
Study Arms (2)
Repetitive recruitment with PEEP
EXPERIMENTALOne alveolar recruitment at before surgery and repetitive alveolar recruitment (once an hour) during surgery
One recruitment with PEEP
ACTIVE COMPARATOROne alveolar recruitment at before surgery
Interventions
Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before suegery and once an hour during surgery. PEEP is set to 7 cmH2O.
Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before surgery. PEEP is set to 7 cmH2O.
Eligibility Criteria
You may qualify if:
- Children undergoing general anesthesia with prone position
- Endotracheal intubation and mechanical ventilation during general anesthesia
- Operation time is more than 2 hours
You may not qualify if:
- Previous lung surgery
- Any abnormal findings such as atelectasis, pneumothorax, pleural effusion, or pneumonia on preoperative chest X-ray
- Researchers judge (to be inappropriate)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUH
Seoul, Jongnogu, 03080, South Korea
Related Publications (1)
Jang YE, Ji SH, Kim EH, Lee JH, Kim JT, Kim HS. Effect of regular alveolar recruitment on intraoperative atelectasis in paediatric patients ventilated in the prone position: a randomised controlled trial. Br J Anaesth. 2020 May;124(5):648-655. doi: 10.1016/j.bja.2020.01.022. Epub 2020 Mar 10.
PMID: 32169254DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee Kim, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 26, 2018
First Posted
April 3, 2018
Study Start
March 29, 2018
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
April 16, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share