- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555041
Correlation Between Capillary Refill Time and Perfusion Index in Critically Ill Patients (CRIPI)
Correlation Between Capillary Refilling tIme and Perfusion Index in Critically Ill Patients
Assessment of capillary refill time (CRT) is a cornerstone of tissue perfusion monitoring in critically ill patients.
CRT measurement is performed by applying brief and gentle pressure (for a few seconds) to a small area of skin until blanching occurs. CRT is defined as the time, in seconds, required for the skin surface to return to its initial color after release of pressure.
Although CRT is a monitoring tool used on a daily basis in emergency departments and critical care units, its practical measurement modalities remain poorly standardized and time-consuming. Consequently, there is no consensus regarding the most reproducible bedside method for CRT assessment. Moreover, repeated CRT measurements during patient management are resource-intensive in terms of medical time and may raise issues related to healthcare staff availability.
The perfusion index (PI) is a marker of tissue perfusion derived from a pulse oximetry sensor. This monitoring device is routinely used in all critically ill patients. It is placed on the finger and worn continuously, including during patient transport.
Because PI measurement is automatic and continuous, establishing its correlation with CRT could allow for more precise tissue perfusion monitoring while reducing the time burden associated with bedside assessments in critically ill patients.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Neven STEVIC, MD
- Phone Number: +33 4 72 11 28 62
- Email: neven.stevic@chu-lyon.fr
Study Contact Backup
- Name: Martin COUR, MD
- Phone Number: +33 4 72 11 28 50
- Email: martin.cour@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69500
- Recruiting
- Service de Réanimation cardio-vasculaire et thoracique, Hôpital Cardiologique louis Pradel, Hospices Civils de Lyon
-
Contact:
- Matthias Matthias JACQUET-LAGREZE, MD
- Phone Number: +33 4 72 35 75 49
- Email: matthias.jacquet-lagreze@chu-lyon.fr
-
Principal Investigator:
- Matthias JACQUET-LAGREZE, MD
-
Lyon, France, 69003
- Recruiting
- Service de Médecine Intensive-Réanimation, Hôpital Édouard Herriot, Hospices Civils de Lyon
-
Contact:
- Neven STEVIC, MD
- Phone Number: +33 4 72 11 28 62
- Email: neven.stevic@chu-lyon.fr
-
Principal Investigator:
- Neven STEVIC, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria :
- Adult patient.
- Admission within the previous 24 hours, or within 24 hours of the onset of a hemodynamic instability criterion (requirement for vasopressors or fluid resuscitation).
- Absence of patient objection.
Exclusion criteria :
- Legal guardianship, curatorship, or judicial protection.
- No social security coverage.
- Morphological abnormalities preventing CRT and IP measurements.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perfusion index (PI) threshold associated with abnormal capillary refill time (CRT)
Time Frame: At the inclusion
|
The primary endpoint will be the PI threshold associated with abnormal CRT (> 3 seconds). CRT is measured in seconds and PI in arbitrary units. These parameters will be measured simultaneously on each patient. Measurements will be performed at the inclusion of each patient. |
At the inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL26_0232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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