Viewing Study NCT06313671



Ignite Creation Date: 2024-05-06 @ 8:15 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06313671
Status: RECRUITING
Last Update Posted: 2024-03-15
First Post: 2024-01-07

Brief Title: Plethysmographic Perfusion Index and Fluid Responsiveness
Sponsor: Avicenna Military Hospital
Organization: Avicenna Military Hospital

Study Overview

Official Title: Reliability of Plethysmographic Perfusion Index to Predict Fluid Responsiveness in Acute Circulatory Failure
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PPI-FR
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
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 09 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None