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NCT05726877 Clinical Trial

Optimal PEEP in Pediatric Patients Under 17 Years of Age.

Ventilation Therapy; Complications Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05726877
Other study ID # 2208-091-1351
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date August 31, 2024

Study information
Verified date January 2023
Source Seoul National University Hospital
Contact Hee-Soo Kim, M.D., Ph.D.
Phone 02-2072-3664
Email dami0605@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 51
Est. completion date August 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 0 Years to 16 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Ventilation Therapy; Complications

Intervention

Other:
• ventilation strategy
Titrating positive end-expiratory pressure

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital 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 Optimal positive end-expiratory pressure (PEEP) result of decremental PEEP trial 10 minutes after intubation
Primary Optimal positive end-expiratory pressure (PEEP) result of decremental PEEP trial 60 minutes after prone positioning
Secondary Impedance tidal variation respiratory parameters measured by Electrical Impedance Tomography (EIT) device 10 minutes after intubation
Secondary Impedance tidal variation respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary regional respiratory system compliance respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary regional respiratory system compliance respiratory parameters measured by EIT device 10 minutes after intubation
Secondary overdistension or atelectasis respiratory parameters measured by EIT device 10 minutes after intubation
Secondary overdistension or atelectasis respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary end-expiratory lung volume respiratory parameters measured by EIT device 10 minutes after intubation
Secondary end-expiratory lung volume respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary end-expiratory lung impedance respiratory parameters measured by EIT device 10 minutes after intubation
Secondary end-expiratory lung impedance respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary regional ventilation delay respiratory parameters measured by EIT device 10 minutes after intubation
Secondary regional ventilation delay respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary center of ventilation respiratory parameters measured by EIT device 10 minutes after intubation
Secondary center of ventilation respiratory parameters measured by EIT device 60 minutes after prone positioning
Secondary vital signs blood pressure (mmHg) 10 minutes after intubation
Secondary vital signs blood pressure (mmHg) 60 minutes after prone positioning
Secondary vital signs oxygen saturation (%) 10 minutes after intubation
Secondary vital signs oxygen saturation (%) 60 minutes after prone positioning
Secondary vital signs heart rate (BPM) 10 minutes after intubation
Secondary vital signs heart rate (BPM) 60 minutes after prone positioning
Secondary arterial blood gas analysis, if patients has arterial catheter oxygen and cardon dioxide tension 10 minutes after intubation & 60 minutes after prone positioning
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