Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: vascular occlusion test using Pediatric SomaSensor for INVOS 5100C

• 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Pediatric patients aged under 8 years old who are scheduled for cardiac surgery

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Exclusion Criteria

• Skin disease
• Skin preparation involving thigh
• Peripheral vascular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vascular occlusion test (VOT)	vascular occlusion test using Pediatric SomaSensor for INVOS 5100C	Pediatric patients aged under 8 years old are enrolled in this study. VOT is performed in 3 times : after induction of anesthesia, during cardiopulmonary bypass (CPB) for main surgical procedure and after weaning from CPB. The relationship between postoperative outcome variables and the dynamic parameters from VOT, such as desaturation and reoxygenation rate, and reactive hyperemic area, will be evaluated.

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