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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05275309
Other study ID # H2111-072-1272
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2022
Est. completion date December 30, 2022

Study information

Verified date November 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the appropriate positive end-expiratory pressure (PEEP) using electrical impedance tomography (EIT) in children under general anesthesia and to investigate whether there is a difference between the supine and prone positions.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: - Children <= years of age who are scheduled for surgery in the prone position under general anesthesia Exclusion Criteria: - Respiratory distress, bronchopulmonary dysplasia - Pneumothorax - Increased intracranial pressure - History of airway surgery - Cervical or thoracic surgery - Pulmonary hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exploration of optimal PEEP in supine and prone position
General anesthesia is done in routine manner A sensor for electrical impedance tomography (EIT) is applied around the patient's chest. In supine position, lung recruitment maneuver is done, followed by decremental PEEP trial. Based on EIT parameter, optimal PEEP which induces minimal overdistension and collapse of lungs is determined. One hour after prone position, optimal PEEP is determined again.

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 Optimal PEEP level at spine position Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position 10 minutes after intubation (supine)
Primary Optimal PEEP level at prone position Optimal PEEP level (cmH2O) determination using electrical impedance tomography at prone position 1 hour after prone positioning (prone)
Secondary Dynamic compliance measured using Electrical impedance tomography ventilation/pressure (ml/cmH2O) until 1 hour after prone positioning
Secondary regional ventilation delay measured using Electrical impedance tomography ventilation time delay during one breath (no unit) until 1 hour after prone positioning
Secondary pulmonary opening pressure measured using Electrical impedance tomography alveoli opening pressure (cmH2O) until 1 hour after prone positioning
Secondary atelectasis/overdistension ratio measured using Electrical impedance tomography The degree comparing atelectasis and overdistension (no unit) until 1 hour after prone positioning
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