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Testing of a Non-Invasive Light Sensor to Estimate Venous Blood Oxygen Levels in Patients in the Intensive Care Unit (ICU)

Calibration and Validation of a Non-Invasive Optical Sensor for Estimating Venous Oxygen Saturation in Intensive Care Unit (ICU) Patients Compared with Blood Gas Analysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000866404
Acronym
CANVOS
Enrollment
14
Registered
2025-08-11
Start date
2026-04-13
Completion date
2027-02-01
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to test a new sensor that measures how much oxygen is in a patient’s blood without needing repeated blood tests. The sensor sits on the skin over a neck or leg vein and continuously tracks oxygen levels. We will compare the sensor’s readings to gold-standard blood tests taken from existing hospital lines to see how accurate it is. Our goal is to find out whether this non-invasive method can safely and reliably monitor oxygen delivery in critically ill patients.

Interventions

Arm 1: Internal Jugular Vein (JVP) Monitoring WHY: Continuous monitoring of venous oxygen saturation (SvO2) and oxygen extraction ratio (O2ER) using a flexible, non-invasive optical sensor placed over the internal jugular vein (IJV). MATERIALS: • Custom-developed reflectance pulse oximetry sensor with red and infrared LEDs, photodetectors, and integrated temperature protection • Medical-grade adhesive (Tegaderm) • Commercial finger pulse oximeter for SaO2 reference • Blood assays PROCEDURES:

Arm 1: Internal Jugular Vein (JVP) Monitoring WHY: Continuous monitoring of venous oxygen saturation (SvO2) and oxygen extraction ratio (O2ER) using a flexible, non-invasive optical sensor placed over the internal jugular vein (IJV). MATERIALS: • Custom-developed reflectance pulse oximetry sensor with red and infrared LEDs, photodetectors, and integrated temperature protection • Medical-grade adhesive (Tegaderm) • Commercial finger pulse oximeter for SaO2 reference • Blood assays PROCEDURES: • Optional ultrasound imaging to locate the IJV and optimise placement • Sensor placed on the side of the neck, preferably contralateral to the central line • Finger pulse oximeter placed on the same side as the arterial line • Sensor remains in place for up to 24 hours • Blood gas samples (arterial and central venous) are taken per routine care and aligned with sensor data • Sensor is cleaned with alcohol and reused per protocol WHO PROVIDED: Research staff with ICU experience will apply the sensor and monitor performance. HOW: • Face-to-face, bedside monitoring. • Individual use. • Sensor applied and left in place for up to 24 hours. • At least five blood draws made during 24-hour period (T=0, 2, 6, 12, 24 hours) LOCATION: Christchurch Hospital ICU, New Zealand TAILORING: • Sensor placement adjusted for neck anatomy or existing lines. • Signal quality confirmed visually at placement. Arm 2: Femoral Vein Monitoring Identical protocol to Arm 1, but the optical sensor is placed over the femoral vein rather than the jugular vein. Sensor placed over the femoral vein if central access exists and jugular placement is not feasible ADAPTATION: Only used if the internal jugular site is not available or contraindicated. Placement adjusted based Allocation to arms: Participants will initially be allocated to Arm 1 (Internal Jugular Vein monitoring). If an appropriate signal cannot be obtained or maintained from the IJV site, or no jugular catheter is present participants may be switched to Arm 2 (Femoral Vein monitoring) as an alternative site. Number and duration of sensor assessments: Each participant will have a single continuous sensor assessment lasting up to 24 hours. Re-application of the sensor for additional or extended monitoring sessions is not planned within this study. Adherence monitoring strategies: Sensor placement and signal quality will be checked every 2 hours by research staff to ensure proper positioning and data quality. Any issues with sensor adherence or signal loss will be documented.

Sponsors

Geoff Shaw, Department of ICU, Christchurch Hosptial
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• ICU participants with a current or anticipated central line or femoral vein catheter • 18 years of age or older

Exclusion criteria

• Participants who are not expected to survive for 48 hours are excluded from the study • Participants on any medication or therapy that, in the judgment of clinicians, may affect the accuracy and precision of non-invasive oximetry results • Patients unsuited for additional blood sampling, for example, difficulty with blood access or an increased risk for needing blood transfusion (for blood sampling participation)

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026