Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

NCT01760044 | Completed

• 1 other identifier: NATP001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.

Conditions

Sepsis; Shock

Keywords

tissue oxygenation; perfusion status

Outcome Measures

Primary Outcomes (1)

• tissue oxygenation level as measured by raman spectroscopy device

  Measurement of tissue oxygenation level as based upon raman spectroscopy device will be compared with standard measures from central venous oxygen saturation from central venous catheters.

  The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.

Secondary Outcomes (2)

• Microcirculation as recorded by sublingual video microcirculation recorder.

  Twice in the first 24 hours after PICU admission

• Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)

  Continuous from PICU admission through 24 hours of admission

Study Arms (1)

Tissue oxygenation monitoring

EXPERIMENTAL

Tissue oxygenation monitoring

Device: Tissue oxygenation monitoring

Interventions

Tissue oxygenation monitoring DEVICE

The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.

Also known as: R-StO2 (Raman Tissue Oxygenation)

Tissue oxygenation monitoring

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients admitted to the Pediatric Intensive Care Unit (PICU) or Pediatric Cardiothoracic Unit (PCTU)
• Age \>30 days and \<18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava

You may not qualify if:

• Age \<30 days or \>18 years
• Known pregnancy or subsequently discovered pregnancy after admission
• Uncorrected cyanotic congenital heart disease
• Oral trauma preventing placement of Raman StO2 oximeter probe or microcirculation video device
• Upper extremity trauma preventing placement of BEAM device

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sepsis; Shock

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Ward, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Pediatric Critical Care

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

US (1)