NCT05588180

The Ratio Of Femoral Vein Diameter To Femoral Artery Diameter With Pulse Pressure Variation As A Diagnostic Tool

Completed NA Last updated 24 May 2023

What this trial tests

NA trial testing FVD/FAD ratio guided in Mechanically Ventilated Patients in 60 participants. Completed in 20 May 2023.

Timeline

18 October 2022

Primary endpoint
15 May 2023

20 May 2023

Quick facts

Lead sponsor	Fayoum University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	diagnostic
Enrollment	60
Start date	18 October 2022
Primary completion	15 May 2023
Estimated completion	20 May 2023
Sites	1 location across Egypt

Drugs / interventions tested

• FVD/FAD ratio guided
• PPV

Conditions studied

• Mechanically Ventilated Patients — all drugs for Mechanically Ventilated Patients →

Sponsor

Fayoum University Hospital

Who can join

Adults 18 to 60, any sex, with Mechanically Ventilated Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In assessing critically ill patients, an accurate assessment of a patient's volume status and whether they will respond to a fluid challenge with an increase in cardiac output is vital. 1 When hypovolemia is detected, volume expansion is utilized to enhance hemodynamics and restore normal blood pressure. 2 Hemodynamic tests (right atrial pressure, pulmonary artery occlusion pressure, and cardiac output ) are used to assess preload in critically ill patients, although these indexes are not necessarily reliable predictors of fluid status. According to the Starling law, fluid administration is hypothesized to boost cardiac output by raising preload, which describes a positive relationship between cardiac muscle fiber length and contractility. However, the Starling curve hits a plateau beyond its ascending leg, and additional fluid administration can be hazardous, leading to right ventricular overload and pulmonary edema Invasive or noninvasive techniques can be used to determine blood volume status. Assessments such as central venous pressure (CVP) and mean pulmonary artery pressure (mPAP) are both invasive procedures. Various factors influence CVP (including thoracic, pericardial, abdominal pressures, etc.). CVP can be used as a fluid management indication, although It can be misused to estimate blood volume or mislead methods for treatment. Dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are superior to static indices for assessing volume status. However, these dynamic indices are unreliable when a patient is ventilated with low tidal volume, such as acute respiratory distress syndrome (ARDS); the tidal volume is insufficient to change intrathoracic pressure significantly. Ultrasound (US) evaluation of the inferior vena cava (IVC) may help determine fluid status.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.