Evaluation of Perfusion Index Change Post Passive Leg Raising for Fluid Responsiveness in Critically Ill

NCT06063993 | Completed DMC

• 1 other identifier: 27-2023
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral Perfusion Index (PI) has been investigated for its use in hemodynamic monitoring. The PI is derived from the photoelectric plethysmographic signal of the pulse oximeter. The changes in the PI reflect changes in peripheral vasomotor tone. In critically ill patients, the same value was found to represent a very sensitive cutoff point for determining abnormal peripheral perfusion, as defined by a prolonged Capillary Refill Time (CRT). However, age, gender, and ambient temperature have all been shown to affect the measure of CRT in normal volunteers, and the presence of a CRT \> 2 or 3 seconds was not predictive of blood loss in phlebotomized volunteers. In addition, the CRT has been shown to have poor intra-observer agreement when a cutoff a two seconds was used in adult emergency room patients.13 Therefore, PI can be used for monitoring peripheral perfusion in critically ill patients.14PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong). As non-invasive CO monitors (ICON ®) is not available in many centers in our country due to its high cost, we try to validate other simple non-invasive method to be used to assess FR in critically ill patients. The purpose of this study is to investigate the efficacy of pulse-oximeter derived PI measurement in assessment of fluid responsiveness in critically ill patients in comparison with CO response.

Conditions

Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

• Fluid responsiveness

  to detect reliability of PI to detect Fluid responsiveness (FR) in critically ill patients

  during PLR passive leg raising during 60 seconds

Secondary Outcomes (1)

• PI reliability

  by the end of statistical analysis of the study up to one year

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

The study population will be subdivided into two groups; responders and non-responder: * Responders group 1 (R); were defined as those who had increase of 10% in CO from baseline measured by EC after PLR. * Non-responders group 2 (NR); those who had increase of less than 10% in CO from baseline measured by EC after PLR.

You may qualify if:

• The subjects are adults aged ≥18 years old
• admitted tothe intensive care unit of the National Hepatologyand Tropical Medicine Research Institute (NHTMRI).
• Patients with clinical signs of hemodynamic instability i.e. a systolic blood pressure \< 90 mmHg or decrease in systolic blood pressure \> 40 mmHg, signs of organ hypoperfusion as oliguria \< 0.5ml/Kg/hour.

You may not qualify if:

• If there is known peripheral vascular disease
• or ≥ 2 vasopressors with the maximum doses
• or in the presence of nail polish as readings from pulse oximeter will be distortedin these cases
• or if there is contraindication for PLR as uncontrolled hemodynamic status
• intracranial hypertension
• severe chronic obstructive pulmonary disease
• broncho-alveolar fistula
• severe emphysema
• and those with pre-existing comorbidities including severe left and right ventricular dysfunction, severe pulmonary hypertension
• severe obesity (BMI \>40 kg/m2)
• pregnancy.

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

NHTMRI

Cairo, 4260010, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow of intensive care medicine

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: October 3, 2023
• Study Start: August 28, 2023
• Primary Completion: May 30, 2025
• Study Completion: June 18, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

EG (1)