PEEP During Induction of Anesthesia in Small Children

August 14, 2019 updated by: Hee-Soo Kim, Seoul National University Hospital

The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia on Atelectasis Formation and Non-hypoxic Apnea Time in Small Children: a Randomized Controlled Trials

Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
    • Soul-t'ukpyolsi
      • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
        • Hee-Soo Kim

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

1 month to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric patients undergoing general anesthesia using endotracheal intubation

Exclusion Criteria:

  • previous history of lung disease
  • anticipated difficulty in airway management

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: zero positive end expiratory pressure
Other: ZEEP
0 cmH2O positive end expiratory pressure
EXPERIMENTAL: Positive end expiratory pressure
Other: PEEP
7cmH2O positive end expiratory pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of Apnea
Time Frame: from the start of apnea until SpO2 reached 95%, maximum 5 minutes.
from the start of apnea until SpO2 reached 95%, maximum 5 minutes.

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee-Soo Kim, Professor, Seoul National University Hospital

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)

May 21, 2018

Primary Completion (ACTUAL)

August 14, 2019

Study Completion (ACTUAL)

August 14, 2019

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (ACTUAL)

May 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H 1804-100-938

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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