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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Hemodynamic Monitoring; ICU
• Intervention / Treatment: Diagnostic test: Automated echocardiographic inferior vena cava measurement

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Amr S Omar, Md, PhD; Phone Number: 44395897; Email: a_s_omar@yahoo.com
• Study Contact Backup: Name: Praveen Sivadasan, MD; Phone Number: 44395897; Email: PSivadasan@hamad.qa

Study Locations

• Qatar
  • Doha, Qatar, 3050
    • Recruiting
    • Hamad Medical Corporation
    • Contact: Praveen Sivadasan, MD; Phone Number: 44395897; Email: a_s_omar@yahoo.com
    • Contact: Suraj Sudarsanan, MD; Phone Number: 44395897; Email: ssudarsanan@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A prospective, descriptive, single-center study that will examine three techniques for guiding fluid therapy. Patients who are in need of fluid therapy will be identified. The study will be conducted over one year after the approval of the ethical committee. Patients after cardiac surgery will be recuited

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All patients; The IVC will be measured by the automated mode and manual measures will be recorded. All patients will have PPv by LiDCO

Diagnostic test: Automated echocardiographic inferior vena cava measurement; Patients will be place in supine position. view: subcostal view, importantly supine is standard position for IVC measurement, the IVC is larger in the right lateral decubitus position and vice versa, alternatively directly through a transhepatic approach. Measures will be performed in the two dimensional mode close to the hepatic vein (1 - 3cm from the IVC connection to the right atrium). The IVC will be measured by MM-Mode manually and with the automated mode (both measures will be recorded. In the manual mode this measure requires concurrent utilization of M-Mode and two dimensional mode; Other Names: Manual echocardiographic inferior vena cava measurement; LiDCO

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR	before and after the fluid challenge	30 minutes
MAP	before and after the fluid challenge	30 minutes
VTI	before and after the fluid challenge	30 minutes

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Investigators: Principal Investigator: Amr Omar, Md, PhD, Hamad medical corproation

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2022
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (ACTUAL): March 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MRC-01-21-947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No allowed by our corporate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No