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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Trendelenburg Positioning for fluid responsiveness in ICU patients?

Research shows that the Trendelenburg position, which involves tilting a patient so their head is lower than their feet, can help predict fluid responsiveness by observing changes in heart function, like the left ventricular outflow tract velocity time integral (LVOT VTI), in certain surgical patients. This position is often used to temporarily improve heart output and blood pressure in specific patient groups, such as those undergoing surgery or with certain heart conditions. ^{1 2 3 4 5}

Is Trendelenburg positioning safe for use in humans?

Trendelenburg positioning has been used in various studies and is generally considered safe for humans, as it did not significantly affect blood pressure or cardiac output in the studies reviewed. ^{1 2 6 7 8}

How does the Trendelenburg positioning treatment differ from other treatments for fluid responsiveness in ICU patients?

Trendelenburg positioning involves tilting the patient so their head is lower than their feet, which can help predict fluid responsiveness by temporarily increasing blood flow to the heart. This non-invasive method is unique because it uses body positioning rather than medication to assess and potentially improve fluid status in critically ill patients. ^{1 2 4 6 9}

Research Team

Matthew Kheir, MD

Principal Investigator

Lenox Hill Hospital- Northwell Health

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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 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]

References

1. China 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. [2022]

2. Netherlands 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. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

The response to Trendelenburg position is minimally affected by underlying hemodynamic conditions in patients with aortic stenosis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of Trendelenburg and modified trendelenburg positions on cardiac output, blood pressure, and oxygenation: a preliminary study. [2013]

5. United States 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. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Pulse pressure variation and stroke volume variation predict fluid responsiveness in mechanically ventilated patients experiencing intra-abdominal hypertension. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Trendelenburg positioning does not prevent a decrease in cardiac output after induction of anaesthesia with propofol in children. [2013]

8. Pakistan pubmed.ncbi.nlm.nih.gov

The effectiveness of trendelenburg positioning on the cross-sectional area of the right internal jugular vein in obese patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of mild Trendelenburg on central hemodynamics and internal jugular vein velocity, cross-sectional area, and flow. [2016]