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

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06063993

27-2023

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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 bedistortedin 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 rightventricular dysfunction, severe pulmonary hypertension
severe obesity (BMI >40 kg/m2)
pregnancy.

Study Design

August 28, 2023

June 18, 2025

Study Description

After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients age, sex,associated co-morbidities (diabetes mellitus & hypertension).

Continuous blood pressure, continuous electrocardiogram, heart rate (HR), and SpO2 (measured by pulse oximetry).

Patients who are eligible and have signs of hemodynamic instability, PLR will be performed by adjusting the bed and not by manually raising the patient's legs. Bronchial secretions must be carefully aspirated before PLR. If awake, the patient should be informed of what the test involves.PLR should start from the semi-recumbent and not the supine position. Adding trunk lowering tosupine position and leg raisingfor 45° for 60 seconds, this mobilizes venous blood from the large splanchnic compartment, thus magnifying the increasing effects of leg elevation on cardiac preload.18COand PI measurements will be recorded in the same patients.

Connect with a study center

NHTMRI
Cairo, 4260010
Egypt
Site Not Available

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