Tissue Oxygen Use With Combined Arteriovenous Noninvasive Oximetry

NCT06072755 | Completed DMC FDA Device

• 4 other identifiers: 2023-1317SMPH/ANESTHESIOLOGY/ANESTHESIOProtocol Version 9/20/2023FP00002636
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Consumption

Keywords

intensive care; jugular vein catheter; radial artery catheter

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Critically ill adults

Inpatient adults who require internal jugular venous central line and radial arterial line

Device: Finger pulse oximetry probe; Device: Transreflectance oximetry probe

Interventions

Finger pulse oximetry probe DEVICE

This finger probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations.

Critically ill adults

Transreflectance oximetry probe DEVICE

This neck probe will be used to make noninvasive measurements of systemic arterial and central venous oxygen saturations.

Critically ill adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• AABB Foundation: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Aaron S Hess, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: January 11, 2024
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)