Automated Inferior Vena Cava Collapsibility Index Fluid Responsiveness in Ventilated Patients After Cardiac Surgery.

• Conditions: ICU; Hemodynamic Monitoring; Cardiac Surgery
• Interventions: Diagnostic Test: Automated echocardiographic inferior vena cava measurement

• Registration Number: NCT05283590
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

Echocardiographic measurement of inferior vena cava (IVC) collapsibility index (CI) with automated software analyses has been introduced. This study aims to assess the accuracy of IVC-CI (caval index) measurements as well as the ability to track fluid responsiveness (FRes) over time comparing the automated echocardiographic method with the pulse pressure variation (PPV) technique and the manual echocardiographic method in cardiac surgery patients.

Detailed Description

It is expected to have insights about the concordance rate. The automated echocardiographic method of measuring CI method may or may not meet the criteria for interchangeability with the thermodilution technique or the manual echocardiographic method.

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02-12
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Age more than18 years old. 2. Cardiac surgical patients including (coronary artery bypass graft surgery, valvular surgeries, and aortic dissection surgeries) 3. Need for decision to administer IV fluids (hypotension that require assessment and possible fluid boluses defined as a systolic blood pressure less than 90mmHg. Normotensive patients who require fluid therapy with any other manifestation of low perfusion including tachycardia, low urine output, increased core-peripheral temperature gradient, serial increase in serum lactate, and serial increase in base deficit, and normotensive). The endpoint of fluid resuscitation is return normal blood pressure

Exclusion Criteria

-1. Contraindication for fluid administration including acute pulmonary edema. 2. Moderate or more tricuspid valve lesion or pulmonary hypertension (more 50 mmHg) where high central venous pressure is expected 3. Patients on hemodialysis. 4. Patient on intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) 5. Irregular cardiac rhythm: patients with atrial fibrillation or frequent ectopics are excluded.

6. Patients with chest open 7. Poor echocardiography window (The images will be stored and analyzed by senior physician within the ICU certified in echocardiography)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Automated echocardiographic inferior vena cava measurement	The IVC will be measured by the automated mode and manual measures will be recorded. All patients will have PPv by LiDCO

Primary Outcome Measures

Name	Time	Method
Fluid responsiveness rate 500cc of colloids over 10 min.	30 minutes	defined as increase in the stoke volume by 15% after infusion of 500cc of colloids

Secondary Outcome Measures

Name	Time	Method
MAP	30 minutes	before and after the fluid challenge
VTI	30 minutes	before and after the fluid challenge
HR	30 minutes	before and after the fluid challenge

Trial Locations

Locations (1)

Hamad medical corporation; 🇶🇦 Doha, Qatar