Plethysmographic Perfusion Index and Fluid Responsiveness

NCT06313671 | Completed

• 1 other identifier: Perfusion Index - FR study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care.

Conditions

Fluid Responsiveness

Keywords

acute circulatory failure; fluid responsiveness; perfusion index; left ventricular outflow velocity time-integral; echocardiography

Outcome Measures

Primary Outcomes (1)

• Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness.

  Reliability and accuracy of the change in perfusion index to discriminate fluid-responsive patients. Fluid responsiveness is defined by an increase in the left ventricular outflow tract velocity time integral by 15% after fluid loading.

  through study completion, an average of 9 months.

Interventions

Perfusion index DIAGNOSTIC_TEST

The perfusion index (PI) is derived from the plethysmography signal and represents the ratio of pulsatile to non-pulsatile light absorbance of the plethysmography signal. PPG signal.

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

Patients aged 18 and older with acute circulatory failure (ACF). ACF is defined by the presence of signs of tissue hypoperfusion: capillary refill time\>5 seconds, mottling, oliguria \<0.5 mL/kg/h for more than an hour), altered mental status), blood lactate \>2 mmol/L or metabolic acidosis (pH \<7.35 or base excess \>-5). Arterial hypotension is not necessary for the diagnosis of ACF. It is defined by a systolic blood pressure (SBP) \<90 mmHg, a mean arterial pressure (MAP) \<65 mmHg, or a drop in SBP ≥40 mmHg. Shock is defined by the combination of ACF and arterial hypotension.

You may qualify if:

• Patients aged 18 and older with acute circulatory failure (ACF).

You may not qualify if:

• Low echogenicity: the inability to perform echocardiographic measurements according to established recommendations.
• Absence of the plethysmographic signal.

Sponsors & Collaborators

• Avicenna Military Hospital: lead

Study Sites (1)

Avicenna Military Hospital

Marrakesh, Marrakesh Tensift El Haouz, 40000, Morocco

Location

MeSH Terms

Conditions

Shock

Interventions

Perfusion Index

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Intensive Care Medicine - Head of intensive care unit

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: March 15, 2024
• Study Start: February 10, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After study completion for 2 years
• Access Criteria: University members Healthcare providers

Locations

MO (1)