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Clinical Trials/NCT05275283
NCT05275283
Unknown
Not Applicable

Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

Seoul National University Hospital1 site in 1 country94 target enrollmentJanuary 3, 2022
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ConditionsPositive End Expiratory Pressure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Positive End Expiratory Pressure
Sponsor
Seoul National University Hospital
Enrollment
94
Locations
1
Primary Endpoint
Respiratory system compliance
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).

Registry
clinicaltrials.gov
Start Date
January 3, 2022
End Date
December 30, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
  • •SAD was used for mechanical ventilation

Exclusion Criteria

  • •Abdominal distension, risk of pulmonary aspiration
  • •Bronchopulmonary dysplasia/respiratory distress syndrome
  • •Pneumothorax
  • •Airway surgery
  • •Thoracic surgery or laparotomy
  • •Surgery under prone position

Outcomes

Primary Outcomes

Respiratory system compliance

Time Frame: at the end of surgery, about 2 hours after starting of mechanical ventilation

total lung and chest wall compliance, ml/cmH2O

Secondary Outcomes

  • Respiratory system compliance(10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation)
  • oropharyngeal leak pressure(immediate after SAD insertion)
  • Electrical impedance tomography parameter - dynamic compliance(throughout anesthesia (about during 1-3 hours))
  • Electrical impedance tomography parameter - regional ventilation delay(throughout anesthesia (about during 1-3 hours))
  • Electrical impedance tomography parameter - pulmonary opening pressure(throughout anesthesia (about during 1-3 hours))

Study Sites (1)

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