Plethysmographic Perfusion Index and Fluid Responsiveness (PPI-FR)

Reliability of Plethysmographic Perfusion Index to Predict Fluid Responsiveness in Acute Circulatory Failure.

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.

Study Overview

• Status: Completed
• Conditions: Fluid Responsiveness
• Intervention / Treatment: Diagnostic test: Perfusion index

Detailed Description

In patients with acute circulatory failure, it is recommended to assess fluid responsiveness. Fluid responsiveness is defined by an increase in cardiac output of 10 to 15% after fluid loading. The assessment of fluid responsiveness usually needs cardiac output monitoring (or stroke volume). However, in limited resource settings or during the initial management of patients with acute circulatory failure, cardiac output measurement is usually unavailable. The perfusion index (PI) is derived from the plethysmographic signal of the pulse oximeter and represents the ratio between the ratio of pulsatile on non-pulsatile light absorbance of the plethysmography signal. The PI is influenced by vascular and stroke volume. The investigators hypothesized that the peripheral index could track the changes in cardiac output induced by fluid loading and therefore detect fluid responsiveness.

Adult patients with acute circulatory failure in whom physicians want to test the fluid responsiveness will be included. At baseline, the PI will be recorded. An initial echocardiography will be performed to measure the left ventricular outflow tract velocity time integral (a surrogate of stroke volume). A fluid loading with 500 ml of 0.9% Saline or Ringer Lactate will be performed. After fluid administration, the velocity time integral and the PI will be collected. Fluid-responsive patients are defined by a 15% increase in velocity time integral. The investigators will analyze the ability of the PI to detect fluid responsiveness.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Morocco
  • Marrakesh Tensift El Haouz
    • Marrakesh, Marrakesh Tensift El Haouz, Morocco, 40000
      • Avicenna Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Avicenna Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2024
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: echocardiography; fluid responsiveness; perfusion index; acute circulatory failure; left ventricular outflow velocity time-integral
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: Perfusion Index - FR study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
• IPD Sharing Time Frame: After study completion for 2 years
• IPD Sharing Access Criteria: University members Healthcare providers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No