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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287753
• Other study ID #: H-1309-095-522
• Status: Completed
• Phase: N/A
• First received: November 6, 2014
• Last updated: April 19, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• vascular 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 1 years after surgery
Secondary	Length of mechanical ventilation time and ICU stay		up to 1 years after surgery