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

NCT02287753 | Completed DMC

• 1 other identifier: H-1309-095-522
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

vascular occlusion test; near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 1 years after surgery

Secondary Outcomes (2)

• Use of inotropic and vasoactive drugs

  up to 1 years after surgery

• Length of mechanical ventilation time and ICU stay

  up to 1 years after surgery

Study Arms (1)

Vascular occlusion test (VOT)

EXPERIMENTAL

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.

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

Interventions

vascular occlusion test using Pediatric SomaSensor for INVOS 5100C OTHER

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.

Vascular occlusion test (VOT)

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29140967 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

KR (1)