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Clinical Trials/NCT05275283
NCT05275283UnknownNot 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 enrollmentStarted: January 3, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
94
Locations
1
Primary Endpoint
Respiratory system compliance
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
— to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control group

No Intervention

Applying tidal volume 7 ml/kg without PEEP

PEEP group

Experimental

Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP

Intervention: PEEP (Other)

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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Professor

Seoul National University Hospital

Study Sites (1)

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