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

August 21, 2024 updated by: University of Wisconsin, Madison

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Aaron S Hess, MD, PhD
  • Phone Number: 608-263-8100
  • Email: ahess5@wisc.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of digital pulse oximetry
Time Frame: 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
Through study completion, approximately 20 minutes
Accuracy of jugular pulse oximetry
Time Frame: 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
Through study completion, approximately 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AABB Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron S Hess, MD, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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