NCT07555041

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026May 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 29, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 21, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Capillary refill timePerfusion indexMicrocirculationIntensive care

Outcome Measures

Primary Outcomes (1)

  • Perfusion index (PI) threshold associated with abnormal capillary refill time (CRT)

    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

Interventions

Microcirculation monitoring by Capillary Refill Time (CRT) measurements

Also known as: Capillary refill time (CRT) measurements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to a University Hospital, either to a medical or surgical intensive care unit.

You may qualify if:

  • 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.

You may not qualify if:

  • Legal guardianship, curatorship, or judicial protection.
  • No social security coverage.
  • Morphological abnormalities preventing CRT and IP measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Réanimation cardio-vasculaire et thoracique, Hôpital Cardiologique louis Pradel, Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

Service de Médecine Intensive-Réanimation, Hôpital Édouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start

April 29, 2026

Primary Completion (Estimated)

May 29, 2027

Study Completion (Estimated)

May 29, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations