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Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children

Primary Purpose

Hypovolemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
abdominal compression
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypovolemia

Eligibility Criteria

1 Month - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery

Exclusion Criteria:

  • renal, hepatic and pulmonary disease
  • preoperative infection: increased CPR, WBC over 10,000, and with fever
  • genetic and hematologic disease
  • intracardiac and extracardiac shunt
  • single ventricle
  • right heart dysfunction
  • any intracardiac valve pathology
  • increased intracranial pressure

Sites / Locations

  • Seoul national university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric patients with hypovolemia

Arm Description

Right upper abdominal compression is performed in patients with hypovolemic signs including hypotension, decreased urine output and central venous pressure less than 5 mmHg. Changes of blood pressure during abdominal compression is continuously recorded.

Outcomes

Primary Outcome Measures

Changes in cardiac index after volume expansion

Secondary Outcome Measures

Changes in pleth variability index after volume expansion
Changes in respiratory changes of peak aortic blood flow velocities after volume expansion

Full Information

First Posted
June 6, 2015
Last Updated
April 28, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02471534
Brief Title
Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children
Official Title
Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children.
Detailed Description
The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children. When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min. To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration. Finally, patients will be divided into fluid responder group and non-responder group. If cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. Using ROC curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric patients with hypovolemia
Arm Type
Experimental
Arm Description
Right upper abdominal compression is performed in patients with hypovolemic signs including hypotension, decreased urine output and central venous pressure less than 5 mmHg. Changes of blood pressure during abdominal compression is continuously recorded.
Intervention Type
Procedure
Intervention Name(s)
abdominal compression
Intervention Description
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.
Primary Outcome Measure Information:
Title
Changes in cardiac index after volume expansion
Time Frame
before and after fluid administration (20 min)
Secondary Outcome Measure Information:
Title
Changes in pleth variability index after volume expansion
Time Frame
before and after fluid administration (20 min)
Title
Changes in respiratory changes of peak aortic blood flow velocities after volume expansion
Time Frame
before and after fluid administration (20 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery Exclusion Criteria: renal, hepatic and pulmonary disease preoperative infection: increased CPR, WBC over 10,000, and with fever genetic and hematologic disease intracardiac and extracardiac shunt single ventricle right heart dysfunction any intracardiac valve pathology increased intracranial pressure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children

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