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

Not Applicable

• Conditions: Positive End Expiratory Pressure
• Interventions: Other: PEEP

• Registration Number: NCT05275283
• Lead Sponsor: Seoul National University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study Start: 2022-01-03
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-01
• Last Update Submitted: 2022-03-01
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEP group	PEEP	Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP

Primary Outcome Measures

Name	Time	Method
Respiratory system compliance	at the end of surgery, about 2 hours after starting of mechanical ventilation	total lung and chest wall compliance, ml/cmH2O

Secondary Outcome Measures

Name	Time	Method
Respiratory system compliance	10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation	total lung and chest wall compliance, ml/cmH2O
oropharyngeal leak pressure	immediate after SAD insertion	cmH2O
Electrical impedance tomography parameter - dynamic compliance	throughout anesthesia (about during 1-3 hours)	ventilation/airway pressure (cmH2O)
Electrical impedance tomography parameter - regional ventilation delay	throughout anesthesia (about during 1-3 hours)	assessment of ventilation homogeneity (no unit)
Electrical impedance tomography parameter - pulmonary opening pressure	throughout anesthesia (about during 1-3 hours)	pressure requiring opening of alveoli (cmH2O

Trial Locations

Locations (1)

Hee-Soo Kim; 🇰🇷 Seoul, Korea, Republic of