An interventional study of abdominal compression in Hypovolemia, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic
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).
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
133 studies on the registry are indexed under Hypovolemia; 19 are open to participants now.
This study's enrollment of 64 is above the median of 43 across 66 interventional studies indexed under Hypovolemia.
Browse Hypovolemia studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: abdominal compression
When there are clinical signs of hypovolemia, such as hypotension in pediatric patients with single ventricle, 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.
Changes in stroke volume index after volume expansion
Time frame: before and after fluid administration (20 min)
Changes in pleth variability index after volume expansion
Time frame: before and after fluid administration (20 min)
3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion
Time frame: before and after fluid administration (20 min)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital