Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Major adverse event
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pediatric patients aged under 8 years old who are scheduled for cardiac surgery
Exclusion Criteria
- •Skin disease
- •Skin preparation involving thigh
- •Peripheral vascular disease
Outcomes
Primary Outcomes
Major adverse event
Time Frame: 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 Outcomes
- 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)
Investigators
Jin-Tae Kim
assistant professor
Seoul National University Hospital