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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05275309

Collaborator

(none)

Enrollment

Location

Arm

23.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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 supine positions.

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia	Other: Exploration of optimal PEEP in supine and prone position	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 14, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Children <= 6 years old Pediatric patients under 6 years of age scheduled for surgery in the prone position	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.

Arm

Intervention/Treatment

Experimental: Children <= 6 years old

Pediatric patients under 6 years of age scheduled for surgery in the prone position

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.

Outcome Measures

Primary Outcome Measures

Optimal PEEP level at spine position [10 minutes after intubation (supine)]
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position
Optimal PEEP level at prone position [1 hour after prone positioning (prone)]
Optimal PEEP level (cmH2O) determination using electrical impedance tomography at prone position

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children <=6 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hee-Soo Kim	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Hee-Soo Kim, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hee-Soo Kim, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05275309

Other Study ID Numbers:

H2111-072-1272

First Posted:

Mar 11, 2022

Last Update Posted:

Mar 11, 2022

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 11, 2022