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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05275283
Enrollment
94
Registered
2022-03-11
Start date
2022-01-03
Completion date
2023-12-30
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Positive End Expiratory Pressure

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).

Interventions

OTHERPEEP

6 cmH2O of PEEP

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory system complianceat the end of surgery, about 2 hours after starting of mechanical ventilationtotal lung and chest wall compliance, ml/cmH2O

Secondary

MeasureTime frameDescription
Respiratory system compliance10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilationtotal lung and chest wall compliance, ml/cmH2O
oropharyngeal leak pressureimmediate after SAD insertioncmH2O
Electrical impedance tomography parameter - dynamic compliancethroughout anesthesia (about during 1-3 hours)ventilation/airway pressure (cmH2O)
Electrical impedance tomography parameter - regional ventilation delaythroughout anesthesia (about during 1-3 hours)assessment of ventilation homogeneity (no unit)
Electrical impedance tomography parameter - pulmonary opening pressurethroughout anesthesia (about during 1-3 hours)pressure requiring opening of alveoli (cmH2O

Countries

South Korea

Contacts

Primary ContactHee-Soo Kim, MD, PhD
dami0605@snu.ac.kr02-2072-3659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026