Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients

NCT ID: NCT01760044

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-11-30

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.

Detailed Description

Investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation. Measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter. Investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy. Basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.

Conditions

Sepsis; Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Tissue oxygenation monitoring

Tissue oxygenation monitoring

Group Type: EXPERIMENTAL

Tissue oxygenation monitoring

Intervention Type: DEVICE

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

Interventions

Tissue oxygenation monitoring

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

Intervention Type: DEVICE

Other Intervention Names

R-StO2 (Raman Tissue Oxygenation)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Kevin Kuo

Fellow, Pediatric Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Ward, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

NATP001

Identifier Type: -

Identifier Source: org_study_id