Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery
- Conditions
- Congenital Heart Disease
- Registration Number
- NCT02287753
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.
- Detailed Description
After induction of anesthesia, pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. Postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and ICU stay. The relationship between the results of VOT and postoperative outcome will be investigated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- Pediatric patients aged under 8 years old who are scheduled for cardiac surgery
- Skin disease
- Skin preparation involving thigh
- Peripheral vascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Major adverse event up to 1 years after surgery Major adverse event is defined as cardiac compression, re-sternotomy because of hemodynamic instability, ECMO support, Cr\> 2mg/dL, cerebral hemorrhage or infarct and mortality.
- Secondary Outcome Measures
Name Time Method Length of mechanical ventilation time and ICU stay up to 1 years after surgery Use of inotropic and vasoactive drugs up to 1 years after surgery Use of inotropic and vasoactive drugs is evaluated using vasoactive-Inotropic scores (VIS). VIS is calculated as: dopamine dose (㎍/kg/min) + dobutamine dose (㎍/kg/min) + 100 x epinephrine dose (㎍/kg/min) + 10 x milrinone dose (㎍/kg/min) + 10,000 x vasopressin dose (U/kg/min) + 100 x norepinephrine dose (㎍/kg/min).(7) VIS at 0, 24, 48, and 72 hours after surgery ended are collected in all patients.
Trial Locations
- Locations (1)
Seoul national university hospital
🇰🇷Seoul, Korea, Republic of
Seoul national university hospital🇰🇷Seoul, Korea, Republic of