Clinical trial NCT06313671: Plethysmographic Perfusion Index and Fluid Responsiveness
Official title: Reliability of Plethysmographic Perfusion Index to Predict Fluid Responsiveness in Acute Circulatory Failure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Keywords: acute circulatory failure
fluid responsiveness
perfusion index
left ventricular outflow velocity time-integral
echocardiography
Lead sponsor: Avicenna Military Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness.
timeFrame: through study completion, an average of 9 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Marrakesh
country: Morocco
facility: Avicenna Military Hospital
state: Marrakesh Tensift El Haouz
Study officials:
References: