Tissue Perfusion Pressure for Predicting Fluid Responsiveness in Patients With Shock
NCT07670390
Pathologic Processes, Pathological Conditions, Signs and Symptoms
View Trial DetailsNCT Number: NCT06730087
Assessment of validity of electrical cardiometry (EC) to measure fluid responsiveness and extravascular lung water that is expressed in the form of (thoracic fluid content) .
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
faculty of mdicine Assiut university, Asyut, Asyut Governorate, Egypt
The study will be conducted in Assiut University Hospital, in respiratory intensive care unit.
This study is a cross sectional design for Extravascular lung water and fluid responsiveness assessment in critically ill patient
Sample size was calculated using the Buderer's formula for sensitivity and specificity of diagnostic health studies described by Zaidi et. al. 1 For Electrical Cardiometry in the fluid responsiveness group, the following inputs were used: expected sensitivity of Electrical Cardiometry in fluid responsiveness = 81%, expected specificity = 90%, expected sensitivity for ultrasound = 90% (8,9) , desired precision = 10%, and confidence level = 90%. The calculated sample size was 50 cases.
For Electrical Cardiometry in the congestion group, the inputs were: expected sensitivity of Electrical Cardiometry in congestion = 89%, expected specificity = 83%, expected sensitivity for ultrasound = 88% (10,11),desired precision = 10%, and confidence level = 90%. The calculated sample size was 30 cases.
Methods:
Electrocardiometry:
The method of electrical cardiometry requires the use of 4 ECG electrodes, 2 attached to the left side of the neck and 2 attached at the lower thorax. An electrical alternating current (AC) of constant amplitude is applied via the pair of outer electrodes toward the thorax and in particular the ascending and descending aorta. Current is directed toward the aorta because blood is the most conductive material in the thorax. The ratio of applied current and measured voltage equals the conductivity (or bioimpedance), which is recorded over time. The steep increase in conductivity seen beat to beat is attributed to the orientation of red blood cells. The time when the slope is most steep is directly related to the peak aortic blood acceleration (12).
ICON® Parameters Blood Flow SV/SI HR CO/CI Stroke Volume / Stroke Index Heart Rate Cardiac Output /Cardiac Index Vascular System SVR /SVRI Systemic Vascular Resistance/ SVR-Index based on input of MAP and CVP Contractility ICON™ VIC™ STR Index of Contractility Variation of Index of Contractility Systolic Time Ratio (PEP/LVET) CPI Cardiac Performance Index Fluid Status TFC Thoracic Fluid Content SVV Stroke Volume Variation FTC Corrected Flow Time Oxygen Status DO2 / DO2I Oxygen Delivery / DO2-Index based on input of Hemoglobin and SpO2
IVC distensibility index:
In mechanically ventilated patients, the IVC distensibility index is calculated using the formula: IVC distensibility index = [(maximum diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration] (9). fluid responsiveness if it is > 18% (13).
Chest Ultrasonography A zone was considered positive for pulmonary congestion if ≥3 B-lines were shown (14).
Action plan and outcomes
(4) Research outcome measures:
a. Primary (main): electric cardiometry effectiveness in fluid management in critically ill patient b. Secondary (subsidiary):
(5)Data management and analysis (Details needed): Data collection: medical records Computer software IBM SPSS software version 22.0 (SPSS Inc.,Chicago,IL) Statistical tests Statistical tests Normality of data will be assessed using Shapiro walk test. Normally distributed data will be represented as mean ± SD,median9range0 and numbers(%),chi square test or fisher's exac test will be used in categorical data .independent t-test will be used to compare between parametric data,Mann-Whitney will be used to compare non parametric values in the studied groups.p-value<0.05 will be considered statistically significant.
(6)References (max. 15) and written in Vancouver style:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
eria:
-
Time frame: baseline
compairing fluid responsiveness by stroke vloume variation in carddiometry( Fluid responsiveness was defined as SVV >10% to 15%) and IVC destinsability index by ultrasound (fluid rspnisveness was defined as [(maximum IVC diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration] > 18%). compairing pulmonary edema by fluid thoracic content(normal range:25 to 35) in cardiometry and B lines in chest ultrasound(more than 3 b-lines in all 4 fields/BLUE points considered positive for pulmonary edema according to BLUE protocol).
Contact information is provided by the study sponsor or research team.
Mostafa Mahmoud Attia
CONTACT
samiaa hamdy sadek, professr
CONTACT
Assiut University
Other
Extravascular Lung Water and Fluid Responsiveness in Critically Ill Patient
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