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

Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287753
Enrollment
130
Registered
2014-11-11
Start date
2013-11-30
Completion date
2016-12-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

vascular occlusion test, near infrared spectroscopy

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.

Interventions

OTHERvascular occlusion test using Pediatric SomaSensor for INVOS 5100C

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse eventup to 1 years after surgeryMajor 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

MeasureTime frameDescription
Use of inotropic and vasoactive drugsup to 1 years after surgeryUse 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 stayup to 1 years after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026