Trendelenburg Positioning for Fluid Responsiveness in ICU Patients
(TREND-US Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lenox Hill Hospital
Disqualifiers: Pregnancy, Prisoners, Institutionalized, others
No Placebo Group
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.12345
Is Trendelenburg positioning safe for use in humans?
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.12469
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])
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Trial 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 (Procedure)
- VTI (Procedure)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Fluid challenge (control)Experimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lenox Hill Hospital- Northwell HealthNew York, NY
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Who Is Running the Clinical Trial?
Lenox Hill HospitalLead Sponsor
References
Change in left ventricular velocity time integral during Trendelenburg maneuver predicts fluid responsiveness in cardiac surgical patients in the operating room. [2022]Fluid responsiveness is an important topic for clinicians. We investigated whether changes in left ventricular outflow tract (LVOT) velocity time integral (VTI) during a Trendelenburg position (TP) maneuver can predict fluid responsiveness as a non-invasive marker in coronary artery bypass graft (CABG) surgery patients in the operating room.
Non-invasive measurements of pulse pressure variation and stroke volume variation in anesthetized patients using the Nexfin blood pressure monitor. [2018]Nexfin beat-to-beat arterial blood pressure monitoring enables continuous assessment of hemodynamic indices like cardiac index (CI), pulse pressure variation (PPV) and stroke volume variation (SVV) in the perioperative setting. In this study we investigated whether Nexfin adequately reflects alterations in these hemodynamic parameters during a provoked fluid shift in anesthetized and mechanically ventilated patients. The study included 54 patients undergoing non-thoracic surgery with positive pressure mechanical ventilation. The provoked fluid shift comprised 15° Trendelenburg positioning, and fluid responsiveness was defined as a concomitant increase in stroke volume (SV) >10 %. Nexfin blood pressure measurements were performed during supine steady state, Trendelenburg and supine repositioning. Hemodynamic parameters included arterial blood pressure (MAP), CI, PPV and SVV. Trendelenburg positioning did not affect MAP or CI, but induced a decrease in PPV and SVV by 3.3 ± 2.8 and 3.4 ± 2.7 %, respectively. PPV and SVV returned back to baseline values after repositioning of the patient to baseline. Bland-Altman analysis of SVV and PPV showed a bias of -0.3 ± 3.0 % with limits of agreement ranging from -5.6 to 6.2 %. The SVV was more superior in predicting fluid responsiveness (AUC 0.728) than the PVV (AUC 0.636), respectively. The median bias between PPV and SVV was different for patients younger [-1.5 % (-3 to 0)] or older [+2 % (0-4.75)] than 55 years (P
The response to Trendelenburg position is minimally affected by underlying hemodynamic conditions in patients with aortic stenosis. [2018]Trendelenburg positioning is commonly used to temporarily treat intraoperative hypotension. The Trendelenburg position improves cardiac output in normovolemic or anesthetized patients, but not hypovolemic or non-anesthetized patients. Therefore, the response to Trendelenburg positioning may vary depending on patient population or hemodynamic conditions. We thus tested the hypothesis that the effectiveness of the Trendelenburg position, as indicated by an increase in cardiac output, improves after replacement of a stenotic aortic valve. Secondarily, we evaluated whether measurements of left ventricular preload, systolic function, or afterload were associated with the response to Trendelenburg positioning.
The effect of Trendelenburg and modified trendelenburg positions on cardiac output, blood pressure, and oxygenation: a preliminary study. [2013]Although we have insufficient knowledge about the effects of Trendelenburg positions on various hemodynamic parameters, these positions are frequently used to influence cardiac output and blood pressure in critically ill patients.
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]Label="OBJECTIVES">To explore whether the variation of left ventricular outflow tract velocity time integral (LVOT VTI) between positive end-expiratory pressure (PEEP) 10 cmH2O and PEEP 0 cmH2O can predict fluid responsiveness in mechanically ventilated critically ill patients.
Pulse pressure variation and stroke volume variation predict fluid responsiveness in mechanically ventilated patients experiencing intra-abdominal hypertension. [2013]The purpose of the present study was to evaluate whether pulse pressure variation (PPV) and stroke volume variation (SVV) can predict fluid responsiveness in patients with intra-abdominal hypertension (IAH) in either a supine or Trendelenburg position. Forty mechanically ventilated patients that exhibited IAH resulting from carbon dioxide insufflation (up to 12 mmHg) underwent fluid therapy in either a supine or Trendelenburg position. Hemodynamic measurements, including PPV and SVV, were obtained before and after fluid therapy. Prediction of fluid responsiveness (> 10% increase in stroke volume) was performed by linear regression analyses. Baseline PPV and SVV values correlated closely with changes in stroke volume induced by fluid therapy, and were significantly higher in patients that subsequently responded to fluid therapy. Fluid responsiveness in patients in a supine position was predicted by a PPV threshold of > 10.5% and an SVV threshold of > 10.5%. Fluid responsiveness in patients in a Trendelenburg position was predicted by a PPV threshold of > 7.5% and an SVV threshold of > 7.0%. PPV and SVV were demonstrated to be sensitive and specific predictors of fluid responsiveness in patients with IAH in both the supine and Trendelenburg positions.
Trendelenburg positioning does not prevent a decrease in cardiac output after induction of anaesthesia with propofol in children. [2013]Induction of anaesthesia may cause decreased cardiac output and blood pressure. Head-down tilt is often the first clinical step to treat hypotension. The objective of this randomized single centre study was to determine, with the use of impedance cardiography (ICG), whether Trendelenburg positioning modifies the haemodynamic response to propofol/fentanyl induction of anaesthesia in ASA I children.
The effectiveness of trendelenburg positioning on the cross-sectional area of the right internal jugular vein in obese patients. [2022]Trendelenburg positioning is a common approach used during internal jugular vein (IJV) cannulation. No evidence indicates that Trendelenburg positioning significantly increases the cross-sectional area (CSA) of the IJV in obese patients. The primary aim of this study was to determine the effectiveness of Trendelenburg positioning on the CSA of the right internal jugular vein assessed with ultrasound measurement in obese patients.
Effects of mild Trendelenburg on central hemodynamics and internal jugular vein velocity, cross-sectional area, and flow. [2016]Despite widespread use of the Trendelenburg position, its autotransfusion effect remains controversial. Additionally, its adverse effect on cerebral circulation is not generally appreciated. The effects of a 10 degrees head-down tilt on central hemodynamics and flow through the internal jugular vein (IJV) were examined in ten healthy volunteers. Left ventricular end-diastolic volume (LVEDV) and cardiac output (CO) were calculated from two-dimensional echocardiograms. IJV velocity and cross-sectional area were determined by the pulsed Doppler system. Measurements were made with the subjects in the supine position and at 1 minute and 10 minutes after tilting. A significant increase (16%) in CO followed by the increase in LVEDV was observed at 1 minute after tilting, although these changes disappeared after 10 minutes of tilting. Mean arterial pressure at the heart level did not change during the maneuver. The IJV velocity decreased whereas the IJV cross-sectional area increased at 1 minute after tilting, but both factors returned to control level at 10 minutes after tilting. As a result, calculated IJV blood flow was unchanged throughout the period of tilt. Therefore, the mild trendelenburg position produces a transient autotransfusion effect in normovolemic patients. Our data also suggest that the Trendelenburg produces no adverse effect on cerebral circulation in patients with normal cerebral autoregulation.