Trendelenburg Positioning for Fluid Responsiveness in ICU Patients

(TREND-US Trial)

Overseen By Matthew Kheir, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lenox Hill Hospital

Disqualifiers: Pregnancy, Prisoners, Institutionalized, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special body position called Trendelenburg positioning to determine if it helps doctors decide whether ICU patients need more fluids. The study compares this position to the usual fluid administration method and examines changes in blood flow. It targets adults in the ICU who require fluids due to issues like low blood pressure, rapid heart rate, or low urine output. Participants must be able to tolerate lying with their body tilted. As an unphased trial, it provides patients the chance to contribute to medical knowledge that could enhance fluid management in critical care settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Trendelenburg positioning and VTI are safe for ICU patients?

Research has shown that the Trendelenburg position, where patients lie on their back with feet elevated above the head, is generally safe for predicting how ICU patients will respond to fluids. However, some risks exist. Certain studies have found it can be dangerous for individuals with low blood pressure or breathing problems.

The Trendelenburg position serves as a good alternative to other methods, such as leg raising, for predicting if patients will benefit from additional fluids. This aids doctors in deciding whether extra fluids will be useful. However, like any medical procedure, it might not suit everyone. Doctors must consider each patient’s health before using this position. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how Trendelenburg positioning (TP) can help determine fluid responsiveness in ICU patients. Unlike traditional methods that primarily rely on administering a fluid challenge to assess this, TP offers a non-invasive way to evaluate how well a patient's heart can handle and benefit from additional fluids. By using the change in velocity time integral (VTI), an echocardiographic measure, TP could potentially offer a quicker and less resource-intensive option for assessing fluid needs, which is crucial for managing critically ill patients effectively.

What evidence suggests that Trendelenburg positioning and VTI are effective for predicting fluid responsiveness in ICU patients?

This trial will compare the effectiveness of the Trendelenburg position with a fluid challenge in predicting fluid responsiveness in ICU patients. Research has shown that the Trendelenburg position, which involves lying flat with legs raised higher than the head, can help predict how well certain patients will respond to fluid treatment. By observing changes in blood flow, doctors can determine if a patient is likely to benefit from receiving fluids. One study successfully predicted fluid responsiveness in 64.7% of cases using this method. The Trendelenburg position also aids patients with conditions like acute respiratory distress syndrome (ARDS). However, its effectiveness can vary, and some studies suggest it may only be moderately reliable in certain situations. ^{4 6 7 8 9}

Who Is on the Research Team?

Matthew Kheir, MD

Principal Investigator

Lenox Hill Hospital- Northwell Health

Are You a Good Fit for This Trial?

This trial is for ICU patients who are critically ill with conditions like shock, fluid overload, or low cardiac output. It's designed to find out if they'll respond well to fluid therapy without the risk of complications.

Inclusion Criteria

I need fluids due to low blood pressure, fast heart rate, or other signs of low blood volume.

I am 18 years or older and admitted to the ICU.

I can lie on my back with my feet higher than my head.

Exclusion Criteria

Pregnancy

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])

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Echocardiogram performed in supine position to establish baseline VTI

1 day

1 visit (in-person)

Intervention

Participants undergo Trendelenburg positioning and fluid challenge to assess fluid responsiveness

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trendelenburg Positioning
• VTI

Trial Overview

The study tests whether using VTI (a way to measure blood flow) and Trendelenburg positioning (lying on your back with feet higher than head) can predict how well ICU patients will respond to fluids given for their condition.

How Is the Trial Designed?

Group I: Fluid challenge (control) Experimental Treatment 1 Intervention

This study is evaluating the potential of Trendelenburg positioning (TP) in determining fluid responsiveness by using the change in velocity time integral (VTI), and echocardiographic parameter that can be used as a surrogate for stroke volume and cardiac output. There are essentially two arms, whereby the patients is being compared to themselves. The "control arm" is the patient receiving a fluid challenge (FC; IV fluid bolus of 500cc crystalloids- either 0.9% Normal Saline or Lactated Ringer's solution) that the clinician would have given regardless of the study; the change of VTI is collected after administration of IV fluids with comparison to the baseline supine position. The "intervention arm" is the same patient undergoing TP from the baseline supine position to determine the change in VTI after subjecting to TP.

Who Is Running the Clinical Trial?

Lenox Hill Hospital

Lead Sponsor

Trials

7

Recruited

2,700+

Published Research Related to This Trial

In a study of 79 critically ill patients on mechanical ventilation, the change in left ventricular outflow tract velocity time integral (LVOT VTI) between different levels of positive end-expiratory pressure (PEEP) was found to be a strong predictor of fluid responsiveness, with responders showing a significant increase in LVOT VTI compared to nonresponders (17.9% vs 2.1%).

The study demonstrated that the variation in LVOT VTI (ΔVTIPEEP) had a high predictive value for fluid responsiveness, with an area under the curve of 0.935, indicating it can be a reliable tool for clinicians to assess fluid needs in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation of Left Ventricular Outflow Tract Velocity Time Integral at Different Positive End-Expiratory Pressure Levels Can Predict Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients. Zhou, G., Zhang, H., Wang, X., et al.[2022]

In a study involving 10 healthy volunteers, a 10-degree head-down tilt (Trendelenburg position) resulted in a temporary 16% increase in cardiac output and left ventricular end-diastolic volume after 1 minute, indicating a transient autotransfusion effect.

The Trendelenburg position did not adversely affect cerebral circulation in individuals with normal cerebral autoregulation, suggesting it is safe for use in normovolemic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mild Trendelenburg on central hemodynamics and internal jugular vein velocity, cross-sectional area, and flow. Terai, C., Anada, H., Matsushima, S., et al.[2016]

In a study of 40 mechanically ventilated patients with intra-abdominal hypertension, pulse pressure variation (PPV) and stroke volume variation (SVV) were found to be effective predictors of fluid responsiveness, indicating how well patients would respond to fluid therapy.

For patients in a supine position, a PPV threshold of > 10.5% and an SVV threshold of > 10.5% predicted fluid responsiveness, while in a Trendelenburg position, the thresholds were lower at > 7.5% for PPV and > 7.0% for SVV, demonstrating the utility of these measurements in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse pressure variation and stroke volume variation predict fluid responsiveness in mechanically ventilated patients experiencing intra-abdominal hypertension. Liu, X., Fu, Q., Mi, W., et al.[2013]

In a study of 40 obese patients undergoing surgery, the Trendelenburg position did not significantly increase the cross-sectional area (CSA) of the right internal jugular vein (IJV) compared to a flat position, with measurements showing 1.80 cm² in the flat position and 2.08 cm² in the Trendelenburg position.

Surprisingly, in 10 out of 36 patients, the CSA actually decreased when shifting to the Trendelenburg position, suggesting that this common practice may not be beneficial and could potentially hinder IJV cannulation in obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of trendelenburg positioning on the cross-sectional area of the right internal jugular vein in obese patients. Onal, O., Apiliogullari, S., Nayman, A., et al.[2022]

In a study of 65 elective CABG surgery patients, changes in left ventricular outflow tract (LVOT) velocity time integral (VTI) during a Trendelenburg position maneuver were found to be a strong predictor of fluid responsiveness, with a sensitivity of 100% and specificity of 70%.

The study demonstrated that an increase in VTI during the Trendelenburg position correlated well with changes in VTI after a fluid challenge, indicating its potential as a non-invasive marker for assessing fluid responsiveness in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in left ventricular velocity time integral during Trendelenburg maneuver predicts fluid responsiveness in cardiac surgical patients in the operating room. Ma, GG., Xu, LY., Luo, JC., et al.[2022]

The Nexfin monitoring system effectively tracks changes in hemodynamic parameters like pulse pressure variation (PPV) and stroke volume variation (SVV) during fluid shifts in anesthetized patients, demonstrating its utility in perioperative settings with 54 patients studied.

SVV was found to be a better predictor of fluid responsiveness compared to PPV, with a higher area under the curve (AUC) value, indicating that SVV may be more reliable for assessing fluid needs in patients undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive measurements of pulse pressure variation and stroke volume variation in anesthetized patients using the Nexfin blood pressure monitor. Stens, J., Oeben, J., Van Dusseldorp, AA., et al.[2018]

In a study of 37 patients undergoing aortic valve replacement (AVR), the Trendelenburg position led to a significant increase in cardiac output after the surgery, with a median increase of 4% compared to a decrease of 3% before AVR.

Despite the improvement in cardiac output after AVR, the change was considered clinically unimportant, and the effectiveness of the Trendelenburg position was found to be largely independent of the patients' hemodynamic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The response to Trendelenburg position is minimally affected by underlying hemodynamic conditions in patients with aortic stenosis. Sonny, A., Sessler, DI., You, J., et al.[2018]

In a study involving 30 ASA I children aged 7 to 16 undergoing elective surgery, Trendelenburg positioning (head-down tilt) did not improve overall cardiac performance after induction of anesthesia with propofol and fentanyl.

While the head-down group showed lower heart rates and higher stroke volume indices shortly after induction, there was no significant difference in cardiac index or systemic vascular resistance index compared to the supine group, indicating that this positioning may not be effective in managing hemodynamic responses during anesthesia induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trendelenburg positioning does not prevent a decrease in cardiac output after induction of anaesthesia with propofol in children. Kardos, A., Földesi, C., Nagy, A., et al.[2013]

In a preliminary study of 23 cardiac surgery patients, the Trendelenburg and modified Trendelenburg positions did not significantly affect key hemodynamic parameters like cardiac output and blood pressure in those who tolerated the positions.

Five patients experienced discomfort and could not tolerate the Trendelenburg position, suggesting that while these positions are commonly used, they may not be effective or well-tolerated in all critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Trendelenburg and modified trendelenburg positions on cardiac output, blood pressure, and oxygenation: a preliminary study. Ostrow, CL., Hupp, E., Topjian, D.[2013]

Citations

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Although used for this purpose, the Trendelenburg position can be hazardous in some patients. The aim of this study was to compare the effects of the ...

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The Trendelenburg position is a surgical position where the individual lies supine, or flat on their back, with their feet raised higher than their head.

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The Trendelenburg position has been found to predict volume responsiveness in patients with acute respiratory distress syndrome (ARDS) in the prone position [13] ...