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NIRS Guidance Trail in Children's Heart Surgery

NCT02157597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-05-12

No results posted yet for this study

Summary

Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developing sooner than usual. The investigators do not know at this time if they can improve the blood supply to the vital organs. The investigators main aim is to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug Administration (FDA).

The investigators will also follow the progress of recovery after surgery in the Cardiac Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome for children.

Conditions

  • Heart Defects, Congenital

Interventions

OTHER

NIRS based management

1. Check NIRS, mechanics, muscle relaxation, hemodynamics, ventilation, hematocrit, surgical repair 2. Deepen anesthesia with volatile or intravenous agent. 3. Consider Extra-Corporeal Membrane Oxygenation (ECMO).

OTHER

Control

During the Control Arm, the medical team completes all tasks as clinically necessary and in the best medical interest of the patient, without any input from the study procedures

Sponsors & Collaborators

  • American Society of Anesthesiologists

    collaborator OTHER

  • International Anesthesia Research Society (IARS)

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jayant Nick Pratap · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157597 on ClinicalTrials.gov