Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children

May 27, 2020 updated by: Jin-Tae Kim, Seoul National University Hospital

Study on Variables Able to Predict Fluid Responsiveness Using Lung Recruitment Maneuver in Pediatric Patients Undergoing General Anesthesia

Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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, 110-744
        • Seoul National University Hospital

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 undergoing general anesthesia under 6 years old

Exclusion Criteria:

  • arrhythmia
  • <30%, ejection fraction
  • lung disease

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lung recruitment maneuver

Heart rate, mean arterial pressure, stroke volume, pulse pressure variations, pleth variability index, and photoplethysmographic waveform were recorded before lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s), during lung recruitment maneuver when stroke volume reached its minimal value.

Cardiac index measured before and after volume expansion (10ml/kg saline, 0.9%, infused during 10 min). Patients were considered as responders to fluid administration if cardiac index increased greater than or equal to 15%.
Diagnostic test: lung recruitment maneuver
Lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
photoplethysmographic waveform
Time Frame: change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds
change from baseline photoplethysmographic waveform after lung recruitment maneuver within 30 seconds

Collaborators and Investigators

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

Sponsor

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)

June 15, 2017

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 11, 2017

First Posted (ACTUAL)

June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1704-042-836

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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