Oxygen ConsumptionTOUCAN-1NCT06072755
Tissue Oxygen Use With Combined Arteriovenous Noninvasive Oximetry
An observational study of Oxygen Consumption, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Consumption
- What is being tested?
- Finger pulse oximetry probe and Transreflectance oximetry probe
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to 25 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients who already have internal jugular vein and radial artery catheters in place as part of routine clinical care.
Who may be able to join
- Inpatient at the University of Wisconsin University Hospital
- Has an internal jugular venous central line
- Has a radial arterial line
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oxygen Consumption
- Being tested
- Finger pulse oximetry probe, Transreflectance oximetry probe
- Keywords
- intensive care, jugular vein catheter, radial artery catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger pulse oximetry probeDevice
This finger probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations.
Transreflectance oximetry probeDevice
This neck probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill adults | Inpatient adults who require internal jugular venous central line and radial arterial line Receives: Device: Finger pulse oximetry probe; Device: Transreflectance oximetry probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of digital pulse oximetry
Difference in the standard deviation of the arteriovenous saturation difference comparing noninvasive photoplethysmography to invasive blood sampling and oximetry
Measured: 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
Measured: Through study completion, approximately 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Jan 2024
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ConsumptionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- AABB Foundation
- Responsible party
- Sponsor
- Investigators
- Aaron S Hess, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072755
- Sponsor's protocol ID
- 2023-1317
- Other IDs
- SMPH/ANESTHESIOLOGY/ANESTHESIO, Protocol Version 9/20/2023, FP00002636
- Acronym
- TOUCAN-1
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Tissue Oxygenation Monitoring With Noninvasive Jugular Venous Oximetry
- ClinicalTrials.gov ID
- NCT06072755
- Acronym / sponsor ID
- TOUCAN-1 / 2023-1317
- Conditions
- Oxygen Consumption
- Keywords
- intensive care, jugular vein catheter, radial artery catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- AABB Foundation
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill adults | – | Device: Finger pulse oximetry probe, Device: Transreflectance oximetry probeInpatient adults who require internal jugular venous central line and radial arterial line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients who already have internal jugular vein and radial artery catheters in place as part of routine clinical care.
Key inclusion criteria (3 listed)
- Inpatient at the University of Wisconsin University Hospital
- Has an internal jugular venous central line
- Has a radial arterial line
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger pulse oximetry probeThis finger probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations. | Device | Critically ill adults |
| Transreflectance oximetry probeThis neck probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations. | Device | Critically ill adults |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron S Hess, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Consumption, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of digital pulse oximetry (time frame: Through study completion, approximately 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.