Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390423
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness
Sponsor:
CentraCare
Organization:
CentraCare
Study Overview
Official Title:
Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates Such as Pulse Pressure Variation PPV End-tidal CO2 Carbon Dioxide Bioreactance Stroke Volume Index -SVI and Velocity Time Integral on Echocardiographic Exam for Fluid Responsiveness in Patients With Moderately Severe ARDS Acute Respiratory Distress Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PHOENIX
Brief Summary:
In the critically ill population fluid administration in an unstable patient is perhaps the most common intervention that is performed Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS Adult respiratory distress syndrome can increase mortality It has been estimated that only 50 of hemodynamically unstable critically ill patients are volume responsive hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus
Detailed Description:
Fluid responsiveness in patients with moderate to severe ARDS is crucial as additional unnecessary fluid may be harmful Various techniques of hemodynamic assessment exist each with its own advantages and limitations This study compares different techniques of preload responsiveness that include passive leg raise PLR and mini-fluid challenge induced changes in Pulse pressure variation PPV End tidal CO2 Bioreactance based Stroke volume index SVI and velocity time integral VTI on Echocardiogram
Study protocol
Baseline Echo with VTI will be obtained Bed side monitor will be set to display PPV and end tidal CO2 Baxter Starling system will be connected to the patient All baseline values will be recorded Tidal volume will be temporarily adjusted to 8 mlkg which will be reverted back to 6mlkg after the measurements This has proven to be a safe maneuver
All the above hemodynamic assessments will be performed for eligible patients by measuring before and after PLR and repositioning to baseline VTI will be estimated by bed side Echocardiogram SVI will be estimated using the Starling system Baxter PPV and End tidal CO2 will be recorded from the bed side monitors
Fluid responsiveness is presumed with a change in VTI of 10 For these patients a mini-fluid challenge of 250 cc of crystalloids NS RL or Normosol will be given over 10 min and PPV VTI End tidal CO2 and SVI will be recorded before and after fluid challenge Patients with VTI change of 10 as non-responders who will also be included in the analysis for assessment of reliability using the ROC curves hemodynamic assessments and repeated fluid challenge will be considered as needed Stability of vasopressor dose with maximum of 500 cc of crystalloid will be considered as positive fluid responder This cohort of patients will be considered as gold standard for preload responsiveness and will be categorized based on a nominal scale Patients who need higher vasopressor support despite 1L of crystalloid within 3 hours will be considered fluid non-responders
Data collection
De-identified data will be recorded Age BMI body mass index Charleston co-morbidity index baseline PPV End-tidal CO2 SVI VTI post PLR post fluid challenge return to baseline PF ratio PEEP positive end-expiratory pressure SOFA sequential organ function assessment Score on the day of the test will be recorded
Statistical Analysis
Microsoft Excel will be used to record data on an institutional computer Once the data is collected it will be exported for statistical analysis Jamovi will be utilized for statistical analysis Baseline characteristics will be compared using a T-test if normative distribution or non-parametric test such as Mann Whitney U test Reliability and accuracy will be detected using ROC curve assessment In addition the Youden index approach will be utilized to identify cut-offs of each of the variables and their change PPV SVIVTI and End tidal CO2 All the delta values will be compared with pearson correlation with a scatter plot and line of identity Agreement between variables will be done using Bland-Altman analysis If necessary values will be transformed into Z scores For all comparisons a p-value of 005 was considered significant
Study protocol
Baseline Echo with VTI will be obtained Bed side monitor will be set to display PPV and end tidal CO2 Baxter Starling system will be connected to the patient All baseline values will be recorded Tidal volume will be temporarily adjusted to 8 mlkg which will be reverted back to 6mlkg after the measurements This has proven to be a safe maneuver
All the above hemodynamic assessments will be performed for eligible patients by measuring before and after PLR and repositioning to baseline VTI will be estimated by bed side Echocardiogram SVI will be estimated using the Starling system Baxter PPV and End tidal CO2 will be recorded from the bed side monitors
Fluid responsiveness is presumed with a change in VTI of 10 For these patients a mini-fluid challenge of 250 cc of crystalloids NS RL or Normosol will be given over 10 min and PPV VTI End tidal CO2 and SVI will be recorded before and after fluid challenge Patients with VTI change of 10 as non-responders who will also be included in the analysis for assessment of reliability using the ROC curves hemodynamic assessments and repeated fluid challenge will be considered as needed Stability of vasopressor dose with maximum of 500 cc of crystalloid will be considered as positive fluid responder This cohort of patients will be considered as gold standard for preload responsiveness and will be categorized based on a nominal scale Patients who need higher vasopressor support despite 1L of crystalloid within 3 hours will be considered fluid non-responders
Data collection
De-identified data will be recorded Age BMI body mass index Charleston co-morbidity index baseline PPV End-tidal CO2 SVI VTI post PLR post fluid challenge return to baseline PF ratio PEEP positive end-expiratory pressure SOFA sequential organ function assessment Score on the day of the test will be recorded
Statistical Analysis
Microsoft Excel will be used to record data on an institutional computer Once the data is collected it will be exported for statistical analysis Jamovi will be utilized for statistical analysis Baseline characteristics will be compared using a T-test if normative distribution or non-parametric test such as Mann Whitney U test Reliability and accuracy will be detected using ROC curve assessment In addition the Youden index approach will be utilized to identify cut-offs of each of the variables and their change PPV SVIVTI and End tidal CO2 All the delta values will be compared with pearson correlation with a scatter plot and line of identity Agreement between variables will be done using Bland-Altman analysis If necessary values will be transformed into Z scores For all comparisons a p-value of 005 was considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None