Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children
1 other identifier
interventional
47
1 country
1
Brief Summary
The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 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
May 11, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedStudy Start
First participant enrolled
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2019
CompletedMarch 25, 2020
November 1, 2019
1 year
May 11, 2018
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean respiratory compliance
Mean static and dynamic compliance
During 15 minutes after applying each level of PEEP
Secondary Outcomes (2)
Compliance profile
During 15 minutes after applying each level of PEEP
Airway resistance
During 15 minutes after applying each level of PEEP
Study Arms (1)
Children
EXPERIMENTALChildren who receive elective surgery under general anesthesia and are supported by mechanical ventilation
Interventions
The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated.
Eligibility Criteria
You may qualify if:
- Children undergoing surgery more than 1 hour under general anesthesia
- American Society Anesthesiologist physical status I, II
You may not qualify if:
- History of lung resection
- History of bronchopulmonary dysplasia or respiratory distress syndrome
- Abnormalities in chest radiography
- Laparoscopic surgery
- Abdominal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.
PMID: 32682552DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, PhD
Seoul National University Hospital, Seoul National University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2018
First Posted
May 23, 2018
Study Start
November 13, 2018
Primary Completion
November 20, 2019
Study Completion
December 20, 2019
Last Updated
March 25, 2020
Record last verified: 2019-11