Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

March 1, 2022 updated by: Hee-Soo Kim, Seoul National University Hospital
The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

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:

  • Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
  • SAD was used for mechanical ventilation

Exclusion Criteria:

  • Abdominal distension, risk of pulmonary aspiration
  • Bronchopulmonary dysplasia/respiratory distress syndrome
  • Pneumothorax
  • Airway surgery
  • Thoracic surgery or laparotomy
  • Surgery under prone position

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Applying tidal volume 7 ml/kg without PEEP
EXPERIMENTAL: PEEP group
Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP
Other: PEEP
6 cmH2O of PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory system compliance
Time Frame: at the end of surgery, about 2 hours after starting of mechanical ventilation
total lung and chest wall compliance, ml/cmH2O
at the end of surgery, about 2 hours after starting of mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory system compliance
Time Frame: 10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
total lung and chest wall compliance, ml/cmH2O
10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation
oropharyngeal leak pressure
Time Frame: immediate after SAD insertion
cmH2O
immediate after SAD insertion
Electrical impedance tomography parameter - dynamic compliance
Time Frame: throughout anesthesia (about during 1-3 hours)
ventilation/airway pressure (cmH2O)
throughout anesthesia (about during 1-3 hours)
Electrical impedance tomography parameter - regional ventilation delay
Time Frame: throughout anesthesia (about during 1-3 hours)
assessment of ventilation homogeneity (no unit)
throughout anesthesia (about during 1-3 hours)
Electrical impedance tomography parameter - pulmonary opening pressure
Time Frame: throughout anesthesia (about during 1-3 hours)
pressure requiring opening of alveoli (cmH2O
throughout anesthesia (about during 1-3 hours)

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)

January 3, 2022

Primary Completion (ANTICIPATED)

December 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2111-073-1272

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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