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

NCT05275309 | Completed

• 1 other identifier: H2111-072-1272
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (2)

• Optimal PEEP level at spine position

  Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position

  10 minutes after intubation (supine)

• 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 Outcomes (4)

• Dynamic compliance measured using Electrical impedance tomography

  until 1 hour after prone positioning

• regional ventilation delay measured using Electrical impedance tomography

  until 1 hour after prone positioning

• pulmonary opening pressure measured using Electrical impedance tomography

  until 1 hour after prone positioning

• atelectasis/overdistension ratio measured using Electrical impedance tomography

  until 1 hour after prone positioning

Study Arms (1)

Children <= 1 years old

EXPERIMENTAL

Pediatric patients \<= 1 years old of age scheduled for surgery in the prone position

Other: Exploration of optimal PEEP in supine and prone position

Interventions

Exploration of optimal PEEP in supine and prone position OTHER

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.

Children <= 1 years old

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children \<= years of age who are scheduled for surgery in the prone position under general anesthesia

You may not qualify if:

• Respiratory distress, bronchopulmonary dysplasia
• Pneumothorax
• Increased intracranial pressure
• History of airway surgery
• Cervical or thoracic surgery
• Pulmonary hypertension

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Hee-Soo Kim

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Supine Position; Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hee-Soo Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: March 11, 2022
• Study Start: March 14, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 20, 2023

Record last verified: 2021-11

Locations

KR (1)