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

NCT ID: NCT03533296

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2019-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Compliance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Children

Children who receive elective surgery under general anesthesia and are supported by mechanical ventilation

Group Type EXPERIMENTAL

Positive end expiratory pressure (PEEP)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Seoul National University College of Medicine

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.

Reference Type DERIVED
PMID: 32682552 (View on PubMed)

Other Identifiers

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H1804-101-938

Identifier Type: -

Identifier Source: org_study_id

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