Evaluation of Fluid Resuscitation in Shocked Patients by EC in Comparison to Transthoracic Echocardiography.
Study Details
Study Description
Brief Summary
In a recent consensus, shock was defined as "a life-threatening, generalized form of acute circulatory failure associated with inadequate oxygen utilization by the cells". Shock is thus a state in which the circulation is unable to deliver sufficient oxygen to meet the demands of the tissues, resulting in cellular dysuria. Hence, Oxygen consumption (VO2) by the tissues becomes limited by oxygen delivery (DO2).In the past, VO2/DO2 relationships were evaluated at the bedside, but this was quite cumbersome and subject to errors in measurements.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Numerous static measures were evaluated as surrogates of fluid status. However, due to the low predictive value of static measures and clinical examination, dynamic measures of fluid responsiveness have been investigated . A meta-analysis determined that the use of dynamic assessment in goal-directed therapy is associated with a decreased risk of death, a shorter length of stay in the intensive care unit, and a shorter duration of mechanical ventilation .
Transaortic SV increase of 10 to 15 % demonstrated high sensitivity (77-100 %) and specificity (88-99%) for fluid responsiveness.
Thermodilution by pulmonary artery catheter (PAC) has been used as the 'Gold standard' for SV measurements in most studies. However, this requires patients to undergo cardiac catheterization with many complications which led to development of newer methods which are non-invasive .
The ideal monitor should be safe, low-cost, painless, non-invasive, easy to use & interpret and allow for the continuous, hands-free acquisition of accurate data .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A (Electrical cardiometry) It will be performed by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3). Four sensors of EC will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of anterior axillary line). The ICON continuously displays HR, SV and CO |
Device: Group I
Electrical cardiometry measurements will be done immediately before fluid resuscitation and every 30 min till MAP > 65 mmHg: HR,SV.,SVI. ,CO. ,CI and Index of contractility (ICON).
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| Group B (Transthoracic echocardiography) It will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler), respectively. The machine's built-in software uses the formula to calculate CO: |
Device: Group II
measurements will be done immediately before fluid resuscitation and every 30 min till MAP > 65 mmHg: HR.,Left ventricle outflow tract (LVOT) diameter, LVOT area.,• Velocity time integral (VTI),Stroke volume (SV), Stroke volume index (SVI), Cardiac output (CO),Cardiac index (CI).
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Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy of Electrical cardiometry (EC) to predict fluid responsiveness. [Intraoperative and every 30 min till MAP>65mmHg]
Electrical cardiometry will be done be done immediately before fluid resuscitation and every 30 min till MAP > 65 mmHg
Secondary Outcome Measures
- Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challenge. [Intraoperative]
Fluid resuscitation will be done by intravenous infusion of lactated ringer guided by fluid responsiveness (22) (fluid responder if SV increases by > 10% after the fluid challenge (23)). If the patient becomes fluid non-responder, vasopressor infusion or inotrope will start. The end of the study is when MAP > 65 mmHg (either by fluid or both fluid and vasopressor).
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients aged from 19 to 65 years old, with clinical criteria of shock [mean arterial pressure (MAP) ≤ 65 mmHg and tissue hypoperfusion (ScvO2 <70%, P(cv-a) CO2 ≥6 mmHg, CRT ≥4 s and lactate >2mmol/l).
Exclusion Criteria:
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Refusal to sign the consent by a first degree relative.
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Previous cardiac disease, rhythm other than sinus rhythm or heart rate > 140 beat/min.
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Renal failure (acute or chronic).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Al-Azhar University | Cairo | Egypt | 11651 |
Sponsors and Collaborators
- Al-Azhar University
Investigators
- Principal Investigator: Ahmed A Abdelraouf, MD, Resident of Anesthesiology, Surgical Intensive Care and Pain, Faculty of Medicine.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0345/2023