Prediction of Fluid Responsiveness in Children With Single Ventricle
- Conditions
- Hypovolemia
- Interventions
- Procedure: abdominal compression
- Registration Number
- NCT02826135
- Lead Sponsor
- Seoul National University Hospital
- 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 with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).
- 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 with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output or decreased central venous pressure, 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery
- Patients with bidirectional cavopulmonary shunt or fontan tract
- renal, hepatic and pulmonary disease
- preoperative infection: increased CPR, WBC over 10,000, and with fever
- genetic and hematologic disease
- ventricular dysfunction
- increased intracranial pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pediatric patients with hypovolemic state abdominal compression Right upper abdominal compression is performed in patients with hypovolemic signs including hypotension, decreased urine output or decreased central venous pressure. Changes of blood pressure during abdominal compression is continuously recorded.
- Primary Outcome Measures
Name Time Method Changes in stroke volume index after volume expansion before and after fluid administration (20 min)
- Secondary Outcome Measures
Name Time Method Changes in pleth variability index after volume expansion before and after fluid administration (20 min) 3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion before and after fluid administration (20 min)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of