Optimal PEEP in Pediatric Patients Under 17 Years of Age.

Determination of Optimal Positive End-expiratory Pressure in Prone Position During General Anesthesia Using Electrical Impedance Tomography in Pediatric Patient Under 17 Years of Age

This study aimed to investigate the differences in positive end-expiratory pressure titration in the supine and prone positions by age in pediatric patients under 17 years of age who received general anesthesia and then evaluate the hemodynamic stability.

Study Overview

• Status: Recruiting
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Other: ventilation strategy

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee-Soo Kim, M.D., Ph.D.; Phone Number: 02-2072-3664; Email: dami0605@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hee-Soo Kim, M.D.,Ph.D.; Phone Number: 02-2072-3664; Email: dami0605@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who are scheduled to undergo general anesthesia in the prone position
• patients who are in age under 17 years

Exclusion Criteria:

• had cyanosis or chronic respiratory failure
• had respiratory distress syndrome or bronchopulmonary dysplasia
• had laryngotracheal diseases
• had pulmonary hypertension
• receiving oxygen therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental arm; All patients will be enrolled in the same arm.	Other: ventilation strategy; Titrating positive end-expiratory pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal positive end-expiratory pressure (PEEP)	result of decremental PEEP trial	10 minutes after intubation
Optimal positive end-expiratory pressure (PEEP)	result of decremental PEEP trial	60 minutes after prone positioning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impedance tidal variation	respiratory parameters measured by Electrical Impedance Tomography (EIT) device	10 minutes after intubation
Impedance tidal variation	respiratory parameters measured by EIT device	60 minutes after prone positioning
regional respiratory system compliance	respiratory parameters measured by EIT device	60 minutes after prone positioning
regional respiratory system compliance	respiratory parameters measured by EIT device	10 minutes after intubation
overdistension or atelectasis	respiratory parameters measured by EIT device	10 minutes after intubation
overdistension or atelectasis	respiratory parameters measured by EIT device	60 minutes after prone positioning
end-expiratory lung volume	respiratory parameters measured by EIT device	10 minutes after intubation
end-expiratory lung volume	respiratory parameters measured by EIT device	60 minutes after prone positioning
end-expiratory lung impedance	respiratory parameters measured by EIT device	10 minutes after intubation
end-expiratory lung impedance	respiratory parameters measured by EIT device	60 minutes after prone positioning
regional ventilation delay	respiratory parameters measured by EIT device	10 minutes after intubation
regional ventilation delay	respiratory parameters measured by EIT device	60 minutes after prone positioning
center of ventilation	respiratory parameters measured by EIT device	10 minutes after intubation
center of ventilation	respiratory parameters measured by EIT device	60 minutes after prone positioning
vital signs	blood pressure (mmHg)	10 minutes after intubation
vital signs	blood pressure (mmHg)	60 minutes after prone positioning
vital signs	oxygen saturation (%)	10 minutes after intubation
vital signs	oxygen saturation (%)	60 minutes after prone positioning
vital signs	heart rate (BPM)	10 minutes after intubation
vital signs	heart rate (BPM)	60 minutes after prone positioning
arterial blood gas analysis, if patients has arterial catheter	oxygen and cardon dioxide tension	10 minutes after intubation & 60 minutes after prone positioning

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Hee-Soo Kim, MD.Ph.D., Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): August 31, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2208-091-1351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No