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Completed

NCT Number: NCT02952651

Prediction of Fluid Responsiveness in Children Undergoing Major Surgery

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.

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Key information

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Seoul, Jongro Gu, 15710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse oximeter

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Prediction of Fluid Responsiveness Using Respiratory Variation in Pulse Oximeter Plethysmography in Children Undergoing Major Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2016
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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