Tissue Oxygen Use With Combined Arteriovenous Noninvasive Oximetry (TOUCAN-1)

Bedside Tissue Oxygenation Monitoring With Noninvasive Jugular Venous Oximetry

The goal of this observational study is to find out if researchers can measure oxygen consumption in the body without having to draw blood from lines in arteries and central veins.

Participants will undergo measurements of arterial blood oxygen saturation using both finger and neck pulse oximeters.

Study Overview

• Status: Completed
• Conditions: Oxygen Consumption
• Intervention / Treatment: Device: Finger pulse oximetry probe; Device: Transreflectance oximetry probe

Detailed Description

TOUCAN-1 is a study to estimate the accuracy and precision of pulse oximetry as a noninvasive tool for oxygen consumption measurement. Researchers will use a pair of commercially-available, noninvasive pulse oximeters to estimate the oxygen saturation of blood in the internal jugular vein, and compare it to the directly measured oxygen saturation in sampled jugular blood. Researchers will then measure the arterial oxygen saturation in a finger, and compare it to the directly measured oxygen saturation in sampled radial arterial blood.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients who already have internal jugular vein and radial artery catheters in place as part of routine clinical care.

Description

Inclusion Criteria:

• Inpatient at the University of Wisconsin University Hospital
• Has an internal jugular venous central line
• Has a radial arterial line

Exclusion Criteria:

• Currently receiving extracorporeal membrane oxygenation (ECMO)
• Currently receiving continuous renal replacement therapy (CRRT/CVVH)
• All usable lumens of the participant's jugular catheter are in use, and interruption of any medical or therapy through any lumen would, in the view of the primary care team, compromise the participant's care.
• Jugular venous catheter is not functional or position is not confirmed by radiography
• Arterial cannula is not functional
• Known history of sickle cell anemia or other hemoglobinopathy

• Therapy with any of the following medications:

  • Nitroprusside
  • Hydroxocobalamin
  • Indocyanine green
  • Norepinephrine
  • Vasopressin
  • Epinephrine
  • Any other medication or therapy that, in the judgement of the study investigators, may affect the accuracy and precision of the noninvasive oximetry results

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill adults; Inpatient adults who require internal jugular venous central line and radial arterial line	Device: Finger pulse oximetry probe; This finger probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations.; Device: Transreflectance oximetry probe; This neck probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of digital pulse oximetry	Difference in the standard deviation of the arteriovenous saturation difference comparing noninvasive photoplethysmography to invasive blood sampling and oximetry	Through study completion, approximately 20 minutes
Accuracy of jugular pulse oximetry	Difference in the standard deviation of the arteriovenous saturation difference comparing noninvasive photoplethysmography to invasive blood sampling and oximetry	Through study completion, approximately 20 minutes

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: AABB Foundation
• Investigators: Principal Investigator: Aaron S Hess, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: intensive care; jugular vein catheter; radial artery catheter
• Other Study ID Numbers: 2023-1317; SMPH/ANESTHESIOLOGY/ANESTHESIO (Other Identifier: UW Madison); Protocol Version 9/20/2023 (Other Identifier: UW Madison); FP00002636 (Other Grant/Funding Number: AABB Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No