Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
vascular occlusion test using Pediatric SomaSensor for INVOS 5100C
Sponsored by
About this trial
This is an interventional supportive care trial for Congenital Heart Disease focused on measuring vascular occlusion test, near infrared spectroscopy
Eligibility Criteria
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
Sites / Locations
- Seoul national university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vascular occlusion test (VOT)
Arm Description
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.
Outcomes
Primary Outcome Measures
Major adverse event
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
Use of inotropic and vasoactive drugs
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.
Length of mechanical ventilation time and ICU stay
Full Information
NCT ID
NCT02287753
First Posted
November 6, 2014
Last Updated
April 19, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02287753
Brief Title
Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery
Official Title
Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
vascular occlusion test, near infrared spectroscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vascular occlusion test (VOT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
vascular occlusion test using Pediatric SomaSensor for INVOS 5100C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major adverse event
Description
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.
Time Frame
up to 1 years after surgery
Secondary Outcome Measure Information:
Title
Use of inotropic and vasoactive drugs
Description
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.
Time Frame
up to 1 years after surgery
Title
Length of mechanical ventilation time and ICU stay
Time Frame
up to 1 years after surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29140967
Citation
Lee JH, Jang YE, Song IK, Kim EH, Kim HS, Kim JT. Near-Infrared Spectroscopy and Vascular Occlusion Test for Predicting Clinical Outcome in Pediatric Cardiac Patients: A Prospective Observational Study. Pediatr Crit Care Med. 2018 Jan;19(1):32-39. doi: 10.1097/PCC.0000000000001386.
Results Reference
derived
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Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery
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