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

Seoul National University

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Other: vascular occlusion test using Pediatric SomaSensor for INVOS 5100C

Study type: Interventional

Funder types: Other

Identifiers

NCT02287753

H-1309-095-522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: Under 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Vascular occlusion test (VOT)

Experimental group

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.

Treatment:

Other: vascular occlusion test using Pediatric SomaSensor for INVOS 5100C