Plethysmographic Perfusion Index and Fluid Responsiveness

Fluid Responsiveness Clinical Trial

— PPI-FR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313671
• Other study ID #: Perfusion Index - FR study
• Status: Recruiting
• Start date: February 10, 2024
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Avicenna Military Hospital
• Contact: Younes Aissaoui, MD
• Phone: +212661403332
• Email: younes.aissaoui[@]live.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Responsiveness
• Shock

Intervention

Diagnostic Test:
• Perfusion index
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.

Locations

Country	Name	City	State
Morocco	Avicenna Military Hospital	Marrakesh	Marrakesh Tensift El Haouz

Sponsors (1)

Lead Sponsor	Collaborator
Avicenna Military Hospital

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.