TOUCAN-1: Tissue Oxygen Use With Combined Arteriovenous Noninvasive Oximetry

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06072755

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Oxygen Consumption	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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Tissue Oxygen Use With Combined Arteriovenous Noninvasive Oximetry (TOUCAN-1): Determining the Precision and Accuracy of Combined Finger Pulse Oximetry and Jugular Transreflectance Oximetry to Estimate Global Oxygen Use

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator: Aaron S Hess, MD, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT06072755

Other Study ID Numbers:

2023-1317
SMPH/ANESTHESIOLOGY/ANESTHESIO
Protocol Version 9/20/2023

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Wisconsin, Madison

intensive care

jugular vein catheter

radial artery catheter

Study Results

No Results Posted as of Oct 10, 2023