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

Positive End Expiratory Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275283
• Other study ID #: 2111-073-1272
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2022
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim, MD, PhD
• Phone: 02-2072-3659
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Positive End Expiratory Pressure

Intervention

Other:
• PEEP
6 cmH2O of PEEP

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory system compliance	total lung and chest wall compliance, ml/cmH2O	at the end of surgery, about 2 hours after starting of mechanical ventilation
Secondary	Respiratory system compliance	total lung and chest wall compliance, ml/cmH2O	10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
Secondary	oropharyngeal leak pressure	cmH2O	immediate after SAD insertion
Secondary	Electrical impedance tomography parameter - dynamic compliance	ventilation/airway pressure (cmH2O)	throughout anesthesia (about during 1-3 hours)
Secondary	Electrical impedance tomography parameter - regional ventilation delay	assessment of ventilation homogeneity (no unit)	throughout anesthesia (about during 1-3 hours)
Secondary	Electrical impedance tomography parameter - pulmonary opening pressure	pressure requiring opening of alveoli (cmH2O	throughout anesthesia (about during 1-3 hours)