Clinical trial NCT05726877: Optimal PEEP in Pediatric Patients Under 17 Years of Age.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilation Therapy; Complications
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 51
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Optimal positive end-expiratory pressure (PEEP)
timeFrame: 10 minutes after intubation
measure: Optimal positive end-expiratory pressure (PEEP)
timeFrame: 60 minutes after prone positioning
Secondary outcomes:
measure: Impedance tidal variation
timeFrame: 10 minutes after intubation
measure: Impedance tidal variation
timeFrame: 60 minutes after prone positioning
measure: regional respiratory system compliance
timeFrame: 60 minutes after prone positioning
measure: regional respiratory system compliance
timeFrame: 10 minutes after intubation
measure: overdistension or atelectasis
timeFrame: 10 minutes after intubation
measure: overdistension or atelectasis
timeFrame: 60 minutes after prone positioning
measure: end-expiratory lung volume
timeFrame: 10 minutes after intubation
measure: end-expiratory lung volume
timeFrame: 60 minutes after prone positioning
measure: end-expiratory lung impedance
timeFrame: 10 minutes after intubation
measure: end-expiratory lung impedance
timeFrame: 60 minutes after prone positioning
measure: regional ventilation delay
timeFrame: 10 minutes after intubation
measure: regional ventilation delay
timeFrame: 60 minutes after prone positioning
measure: center of ventilation
timeFrame: 10 minutes after intubation
measure: center of ventilation
timeFrame: 60 minutes after prone positioning
measure: vital signs
timeFrame: 10 minutes after intubation
measure: vital signs
timeFrame: 60 minutes after prone positioning
measure: vital signs
timeFrame: 10 minutes after intubation
measure: vital signs
timeFrame: 60 minutes after prone positioning
measure: vital signs
timeFrame: 10 minutes after intubation
measure: vital signs
timeFrame: 60 minutes after prone positioning
measure: arterial blood gas analysis, if patients has arterial catheter
timeFrame: 10 minutes after intubation & 60 minutes after prone positioning
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Professor
name: Hee-Soo Kim, MD.Ph.D.
role: STUDY_CHAIR
References: