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Trial record 34 of 619 for:    oximeter

Prediction of Fluid Responsiveness in Children Undergoing Major Surgery

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ClinicalTrials.gov Identifier: NCT02952651
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypovolemia Procedure: Pulse oximeter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prediction of Fluid Responsiveness Using Respiratory Variation in Pulse Oximeter Plethysmography in Children Undergoing Major Surgery
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : January 20, 2018

Arm Intervention/treatment
Experimental: Children with hypovolemic state
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.
Procedure: Pulse oximeter
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 Measures :
  1. The ability of delta POP for prediction of fluid responsiveness in children [ Time Frame: Before and after fluid administration (total 20 min) ]
    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.



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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952651


Locations
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Korea, Republic of
SNUH
Seoul, Jongro Gu, Korea, Republic of, 15710
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02952651     History of Changes
Other Study ID Numbers: H1609-066-791
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes