Clinical trial NCT04538612: DiCART TM Device for Capillary Refill Time Measurement
Official title: DiCART TM Device for Capillary Refill Time Measurement : a Validation Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Perfusion
Keywords: capillary refill time
vascular occlusion test
device
impaired perfusion
healthy volunteers.
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Hence, a device providing a standardized evaluation seems to be helpful.

The aim of the study is to evaluate diagnostic performance of such a device recently developped (DiCART TM), in healthy volunteers experiencing vascular occlusion tests to induce impaired perfusion.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age \> 18 years old
* Informed consent to participate

Exclusion Criteria:

* Vascular disease
* Diabetes mellitus
* Dermatosis
* Cutaneous lesion on a measurement site
* Anemia
* Pregnancy
* Cardiovascular chronic treatment
* Non affiliation to a social security regime
* Involvement in other interventional study

Primary outcomes:
measure: Capillary refill time on the thenar eminence evaluated with DiCART TM device.
timeFrame: 180 minutes
Secondary outcomes:
measure: Capillary refill time evaluated on the knee with DiCART TM device
timeFrame: 180 minutes
measure: Intra -observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.
timeFrame: 180 minutes
measure: Intra -observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.
timeFrame: 180 minutes
measure: Inter-observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.
timeFrame: 180 minutes
measure: Inter-observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.
timeFrame: 180 minutes
measure: Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device
timeFrame: 180 minutes
measure: Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method
timeFrame: 180 minutes
measure: Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .
timeFrame: 180 minutes
measure: Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.
timeFrame: 180 minutes
measure: Capillary refill time measured by mathematical algorithms
timeFrame: 180 minutes
measure: number of patients with cutaneous lesions
timeFrame: 180 minutes
measure: Pain evaluation assessed by numeric rating scale
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Matthias JACQUET-LAGREZE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruste M, Cazenave L, Tardif M, Saint-Jean C, Fellahi JL, Lagreze MJ. Measurement of capillary refill time with a handheld prototype device: a comparative validation study in healthy volunteers. J Clin Monit Comput. 2022 Oct;36(5):1271-1278. doi: 10.1007/s10877-021-00757-2. Epub 2021 Sep 22.