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

Sponsor
Hamad Medical Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05283590
Collaborator
(none)
50
1
15.5
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Automated Inferior Vena Cava Collapsibility Index for Assessing Fluid Responsiveness in Ventilated Patients After Cardiac Surgery.
Actual Study Start Date :
Feb 12, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. HR [30 minutes]

      before and after the fluid challenge

    2. MAP [30 minutes]

      before and after the fluid challenge

    3. VTI [30 minutes]

      before and after the fluid challenge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamad medical corporation Doha Qatar 3050

    Sponsors and Collaborators

    • Hamad Medical Corporation

    Investigators

    • Principal Investigator: Amr Omar, Md, PhD, Hamad medical corproation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hamad Medical Corporation
    ClinicalTrials.gov Identifier:
    NCT05283590
    Other Study ID Numbers:
    • MRC-01-21-947
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 25, 2022