Predictive Variables of the Hemodynamic Effect During the Laparoscopic Surgery in Children (Lapa-BP)

June 14, 2017 updated by: Jin-Tae Kim, Seoul National University Hospital

Study on the Predictive Variables Able to Predict the Hemodynamic Effect of Intra-abdominal Pressure in the Children Undergoing Laparoscopic Surgery

This prospective observational study aimed to identify the intraoperative variables to predict the hemodynamic change according to intra-abdominal pressure in the children undergoing laparoscopic surgery.

The intraoperative variables includes Pulse pressure variation (PPV), systolic pressure variation (SPV), stoke volume variation (SVV), Pulse oximeter plethysmographic waveform amplitude (△POP),and pleth variability index (PVI).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

123

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 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients undergoing laparoscopic surgery

Description

Inclusion Criteria:

  • Pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

  • known arrhythmia
  • known lung disease
  • known cardiac dysfunction (Ejection fraction less than 30%)

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

Cohorts and Interventions

Group / Cohort
Hemodynamically stable
Hemodynamically unstable
Hemodynamically unstable patients are defined as those with a 20% decrease in systolic blood pressure according to the change of intraabdominal pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pleth variability index(PVI)
Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Outcome measure will be assessed before the CO2 desufflation for about 2minutes.

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic pressure variation(SPV)
Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Outcome measure will be assessed before the CO2 desufflation for about 2minutes.
Pulse pressure variation(PPV)
Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Pulse oximeter plethysmographic waveform amplitude (△POP)
Time Frame: Outcome measure will be assessed before the CO2 desufflation for about 2minutes
Outcome measure will be assessed before the CO2 desufflation for about 2minutes

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

August 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • H-1507-039-686

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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