Prediction of Fluid Responsiveness in Children Undergoing Major Surgery
Primary Purpose
Hypovolemia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pulse oximeter
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypovolemia
Eligibility Criteria
Inclusion Criteria:
- Children who will be scheduled for major surgery requiring invasive hemodynamic monitoring
Exclusion Criteria:
- renal, hepatic and pulmonary disease
- preoperative infection: increased C-reactive protein, whith blood cell count over 10,000, and with fever
- genetic and hematologic disease
- ventricular dysfunction
- increased intracranial pressure
Sites / Locations
- SNUH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children with hypovolemic state
Arm Description
Pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds in children with hypovolemic signs including hypotension, decreased urine output and central venous pressure less than 5 mmHg. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min. Delta POP is calculated, and diagnostic power of delta POP for fluid responsiveness will be evaluated.
Outcomes
Primary Outcome Measures
The ability of delta POP for prediction of fluid responsiveness in children
Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Delta POP differs according to contact force. After calculation of each delta POP, we will evaluate the ability to predict fluid responsiveness of delta POP using receiver operating characteristic curve.
Secondary Outcome Measures
Full Information
NCT ID
NCT02952651
First Posted
October 19, 2016
Last Updated
February 26, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02952651
Brief Title
Prediction of Fluid Responsiveness in Children Undergoing Major Surgery
Official Title
Prediction of Fluid Responsiveness Using Respiratory Variation in Pulse Oximeter Plethysmography in Children Undergoing Major Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
January 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate predictability of a respiratory variation in pulse oximeter plethysmography for fluid responsiveness in children undergoing major surgery.
Detailed Description
The purpose of this study is to evaluate predictability of a a respiratory variation in pulse oximeter plethysmography (delta POP) for fluid responsiveness in children undergoing major surgery.
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, the study will be started. At index fingers of both hand, pulse oximeter sensors are applied by gradually increasing the contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then, pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 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 stroke volume index measured using echocardiography increases over 15% after fluid administration, the patient will be fluid responder.
Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Using receiver operating characteristic curve, diagnostic power of delta POPs from different contact forces for fluid responsiveness will be evaluated. In addition, difference between delta POP from low contact force and that from high contact force 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
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children with hypovolemic state
Arm Type
Experimental
Arm Description
Pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds in children with hypovolemic signs including hypotension, decreased urine output and central venous pressure less than 5 mmHg. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min. Delta POP is calculated, and diagnostic power of delta POP for fluid responsiveness will be evaluated.
Intervention Type
Procedure
Intervention Name(s)
Pulse oximeter
Intervention Description
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, POP waveforms are obtained from each index finger, which pulse oximeter sensor is applied by increasing contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then intravenous crystalloid 10 mL/kg is infused for 15 min.
Primary Outcome Measure Information:
Title
The ability of delta POP for prediction of fluid responsiveness in children
Description
Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Delta POP differs according to contact force. After calculation of each delta POP, we will evaluate the ability to predict fluid responsiveness of delta POP using receiver operating characteristic curve.
Time Frame
Before and after fluid administration (total 20 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Children who will be scheduled for major surgery requiring invasive hemodynamic monitoring
Exclusion Criteria:
renal, hepatic and pulmonary disease
preoperative infection: increased C-reactive protein, whith blood cell count over 10,000, and with fever
genetic and hematologic disease
ventricular dysfunction
increased intracranial pressure
Facility Information:
Facility Name
SNUH
City
Seoul
State/Province
Jongro Gu
ZIP/Postal Code
15710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prediction of Fluid Responsiveness in Children Undergoing Major Surgery
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