Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children

March 24, 2020 updated by: Jin-Tae Kim, Seoul National University Hospital
The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

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 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children undergoing surgery more than 1 hour under general anesthesia
  • American Society Anesthesiologist physical status I, II

Exclusion Criteria:

  • History of lung resection
  • History of bronchopulmonary dysplasia or respiratory distress syndrome
  • Abnormalities in chest radiography
  • Laparoscopic surgery
  • Abdominal surgery

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Children
Children who receive elective surgery under general anesthesia and are supported by mechanical ventilation
Procedure: Positive end expiratory pressure (PEEP)
The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean respiratory compliance
Time Frame: During 15 minutes after applying each level of PEEP
Mean static and dynamic compliance
During 15 minutes after applying each level of PEEP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance profile
Time Frame: During 15 minutes after applying each level of PEEP

We will determine Intratidal compliance-volume profile using the changes in compliance over time

--> I, merely increasing compliance profile; IH, increasing turning into horizontal compliance profile; D, merely decreasing compliance profile; HD, horizontal turning into decreasing compliance profile; IHD, increasing turning into horizontal and further turning into decreasing compliance profile

If compliance profile is I, the PEEP is low. On the other hand, compliance profile is D, PEEP level is considered to be high.
During 15 minutes after applying each level of PEEP
Airway resistance
Time Frame: During 15 minutes after applying each level of PEEP
Mean airway resistance
During 15 minutes after applying each level of PEEP

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital, Seoul National University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 13, 2018

Primary Completion (ACTUAL)

November 20, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 11, 2018

First Posted (ACTUAL)

May 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H1804-101-938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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