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

NCT ID: NCT05283590

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-12
• Study Completion Date: 2023-05-31

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.

Conditions

Hemodynamic Monitoring; ICU; Cardiac Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients

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

Automated echocardiographic inferior vena cava measurement

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Manual echocardiographic inferior vena cava measurement; LiDCO

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amr Omar, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Hamad medical corproation

Locations

Hamad medical corporation

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Amr S Omar, Md, PhD

Role: CONTACT

a_s_omar@yahoo.com

44395897

Praveen Sivadasan, MD

Role: CONTACT

PSivadasan@hamad.qa

44395897

Facility Contacts

Praveen Sivadasan, MD

Role: primary

a_s_omar@yahoo.com

44395897

Suraj Sudarsanan, MD

Role: backup

ssudarsanan@hamad.qa

44395897

Other Identifiers

MRC-01-21-947

Identifier Type: -

Identifier Source: org_study_id