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Completed

NCT Number: NCT02471534

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

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children.

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Key information

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

abdominal compression

Procedure

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 outcomes

  1. Changes in cardiac index after volume expansion

    Time frame: before and after fluid administration (20 min)

Secondary outcomes

  1. Changes in pleth variability index after volume expansion

    Time frame: before and after fluid administration (20 min)

  2. Changes in respiratory changes of peak aortic blood flow velocities after volume expansion

    Time frame: before and after fluid administration (20 min)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
May 2, 2016

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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