RecruitingNot ApplicableNCT06418022

Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning

Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning. TREND-US Trial.


Sponsor

Lenox Hill Hospital

Enrollment

400 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Fluid administration is a commonly performed in the ICU for critically ill patients. However, it can lead to complications such as fluid overload, pulmonary edema, and increased mortality in some patients. Therefore, identifying patients who are likely to respond to fluid therapy is crucial for optimizing their management. Several methods have been used to assess fluid responsiveness, such as passive leg raising, stroke volume variation, and cardiac output monitoring. However, these methods have limitations and may not be feasible in all patients. In this study, the investigators aim to evaluate the use of velocity time integral (VTI) and Trendelenburg positioning in predicting fluid responsiveness in ICU patients.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adult patients (≥ 18 years old) admitted to the medical or surgical ICU.
  • Patients who require fluid administration for suspicion of hypovolemia or indicated for volume expansion due to any one of the following: hypotension (systolic blood pressure < 90 mm Hg or mean arterial pressure < 65 mm Hg), tachycardia (heart rate > 100 beats per min), blood lactate > 2.0 mmol/L, skin mottling, oliguria (urine output < 30 ml/hr), or requiring vasopressor/inotrope support.
  • Patients who are able to tolerate the Trendelenburg position.

Exclusion Criteria4

  • Pregnancy.
  • Prisoners and institutionalized patients.
  • Patients who are not able to tolerate the Trendelenburg position. This includes patients with increased intra-cranial hypertension, intra-abdominal hypertension and gastric retention which places a risk for stomach fluid aspiration.
  • Unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable VTI measurements at the left ventricular outflow tract \[LVOT\]).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETrendelenburg positioning VTI

There are essentially two arms, whereby the patients is being compared to themselves. The "intervention arm" is the same patient undergoing TP from the baseline supine position to determine the change in VTI after subjecting to TP. We will be using a Sonosite PX ultrasound system, which is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body and, more specifically, for our echocardiographic measurements of velocity time integral (VTI; surrogate for stroke volume and cardiac output). The Sonosite PX is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals, for evaluation by ultrasound imaging or fluid flow analysis of the human body. This is an FDA-cleared (510K# K200964) commercial device legally marketed in the United States that is being used in accordance with labeling.


Locations(1)

Lenox Hill Hospital- Northwell Health

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06418022


Related Trials