Determination of Optimal Positive End-expiratory Pressure Using Electrical Impedance Tomography in Children Under General Anesthesia: Comparison Between Supine and Prone Positions

January 18, 2023 updated by: Hee-Soo Kim, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children <= 1 years old
Pediatric patients <= 1 years old of age scheduled for surgery in the prone position
Other: Exploration of optimal PEEP in supine and prone position
  1. General anesthesia is done in routine manner
  2. A sensor for electrical impedance tomography (EIT) is applied around the patient's chest.
  3. 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.
  4. One hour after prone position, optimal PEEP is determined again.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal PEEP level at spine position
Time Frame: 10 minutes after intubation (supine)
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position
10 minutes after intubation (supine)
Optimal PEEP level at prone position
Time Frame: 1 hour after prone positioning (prone)
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at prone position
1 hour after prone positioning (prone)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic compliance measured using Electrical impedance tomography
Time Frame: until 1 hour after prone positioning
ventilation/pressure (ml/cmH2O)
until 1 hour after prone positioning
regional ventilation delay measured using Electrical impedance tomography
Time Frame: until 1 hour after prone positioning
ventilation time delay during one breath (no unit)
until 1 hour after prone positioning
pulmonary opening pressure measured using Electrical impedance tomography
Time Frame: until 1 hour after prone positioning
alveoli opening pressure (cmH2O)
until 1 hour after prone positioning
atelectasis/overdistension ratio measured using Electrical impedance tomography
Time Frame: until 1 hour after prone positioning
The degree comparing atelectasis and overdistension (no unit)
until 1 hour after prone positioning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H2111-072-1272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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