Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418022
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-06
Brief Title:
Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning
Sponsor:
Lenox Hill Hospital
Organization:
Lenox Hill Hospital
Study Overview
Official Title:
Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning TREND-US Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREND-US
Brief 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
Detailed Description:
The investigators will perform an echocardiogram both in the supine and Trendelenburg positions for research purposes prior to the ICU team assessing fluid responsiveness see paragraph below
Critically ill patients in which fluid responsiveness is unclear typically admitted to the ICU routinely undergo a bedside echocardiogram in the supine position and then another echocardiogram still in the supine position after receiving IV fluids to assess the patients fluid responsiveness ie whether giving a small IV fluid bolus increases cardiac output VTI is an echocardiographic surrogate for cardiac output and is routinely used in the ICU setting in addition to providing additional information on whether a patient is fluid responsive This method is already standard practice in the medical and surgical ICU in our PCCM department
Unfortunately administering IV fluids can potentially cause adverse events such as pulmonary edema heart failure interstitial edema respiratory failure and death The use of a method such as the passive leg raise maneuver ie raising patients legs by 30 degrees for 1 minute and then evaluating hemodynamic measurements help predict whether a patient would benefit from IV fluids prior to giving them fluids in order to prevent these aforementioned adverse events since it is a reversible process Literature and current practice support the use of the passive leg raise PLR maneuver in predicting fluid responsiveness where an increase of at least 15 signifies a positive fluid response Similar to IV fluids the PLR maneuver can cause adverse events is cumbersome and not feasible in certain circumstances There is recent research which suggests that Trendelenburg positioning TP can be used as an alternative approach that is potentially safer and less cumbersome This study aims to evaluate a cutoff increase in VTI that would be accurate in predicting fluid responsiveness in patients undergoing TP As stated above in our study we will see if placing the patient in TP ie tilt head of the bed 15 degrees downward will predict if the patient is fluid responsive The investigators want use ROC analysis to determine the cutoff VTI increase and the accuracy of using TP in predicting fluid responsiveness The gold standard is to check VTI prior to and after administering an IV fluid bolus and the current literature demonstrates that a VTI increase by 15 is indicative of an appropriate fluid response
The patients in the study in the ICU will receive IV fluids regardless of our study based on the clinicians discretion ie our study will not affect the decision of the clinician in any way The bedside echocardiogram takes less than 2 minutes to perform and will not delay care
Critically ill patients in which fluid responsiveness is unclear typically admitted to the ICU routinely undergo a bedside echocardiogram in the supine position and then another echocardiogram still in the supine position after receiving IV fluids to assess the patients fluid responsiveness ie whether giving a small IV fluid bolus increases cardiac output VTI is an echocardiographic surrogate for cardiac output and is routinely used in the ICU setting in addition to providing additional information on whether a patient is fluid responsive This method is already standard practice in the medical and surgical ICU in our PCCM department
Unfortunately administering IV fluids can potentially cause adverse events such as pulmonary edema heart failure interstitial edema respiratory failure and death The use of a method such as the passive leg raise maneuver ie raising patients legs by 30 degrees for 1 minute and then evaluating hemodynamic measurements help predict whether a patient would benefit from IV fluids prior to giving them fluids in order to prevent these aforementioned adverse events since it is a reversible process Literature and current practice support the use of the passive leg raise PLR maneuver in predicting fluid responsiveness where an increase of at least 15 signifies a positive fluid response Similar to IV fluids the PLR maneuver can cause adverse events is cumbersome and not feasible in certain circumstances There is recent research which suggests that Trendelenburg positioning TP can be used as an alternative approach that is potentially safer and less cumbersome This study aims to evaluate a cutoff increase in VTI that would be accurate in predicting fluid responsiveness in patients undergoing TP As stated above in our study we will see if placing the patient in TP ie tilt head of the bed 15 degrees downward will predict if the patient is fluid responsive The investigators want use ROC analysis to determine the cutoff VTI increase and the accuracy of using TP in predicting fluid responsiveness The gold standard is to check VTI prior to and after administering an IV fluid bolus and the current literature demonstrates that a VTI increase by 15 is indicative of an appropriate fluid response
The patients in the study in the ICU will receive IV fluids regardless of our study based on the clinicians discretion ie our study will not affect the decision of the clinician in any way The bedside echocardiogram takes less than 2 minutes to perform and will not delay care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None