Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery (fluidresponse)

January 31, 2024 updated by: Meltem Sakman Yılmaz, Ankara City Hospital Bilkent
Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery bypass surgery patients ventilated with 6 ml/kg PBW (ideal body weight). We aimed to reveal the sensitivity and specificity of PPV and SVV changes by applying a lung opening maneuver.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In order to evaluate the fluid deficit in patients undergoing coronary artery bypass surgery, researchers will measure stroke volume index, cardiac index and mean arterial pressure while the patients are in the lima position.

Then researchers will perform a lung opening maneuver (30mmHg for 30 seconds) and measure again.

researchers will measure again after the values return to normal. researchers will give patients balanced fluid at 3ml/kg and record their values.

Can researchers predict fluid response with lung opening maneuver?

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia

Description

  • Inclusion Criteria:
  • 1-ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
  • Exclusion Criteria:
  • 1. Be younger than 18 years old, be over 80 years old
  • 2. Patients with an ASA score greater than 3
  • 3. EF<40%
  • 4. Those with contraindications to anesthetic drugs
  • 5. Patients with BMI>30
  • 6. Patients who did not want to participate in the study
  • 7. Right ventricular dysfunction
  • 8. COPD(Chronic obstructive pulmonary disease)
  • 9. Bullous lung disease
  • 10. Moderate to severe PHT
  • 11. Severe kidney or liver disease
  • 12. Patients with hemodynamic instability in the perioperative period
  • 13. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients who will have coroner arter bypass surgeon
Patients undergoing coronary artery bypass surgery will be eliminated if there are exclusion criteria. Patients who do not have exclusion criteria will be included in the study if they agree to volunteer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of fluid responsiveness in patients undergoing coronary arter bypass surgery.
Time Frame: from start to 4 months

: Demonstration of fluid responsiveness in patients who will undergo coronary artery bypass surgery will prevent unnecessary fluid administration in case of hemodynamic disturbance, and medical treatments and interventions can be performed in a timely and targeted manner. Researchers will perform a recruitment maneuver on the patients and record mean arterial pressure and stroke volume index.

Researchers will perform a recruitment maneuver on the patients and record mean arterial pressure and stroke volume index.

Afterwards, researchers will give 3ml/cc balanced fluid to the patient and record the change in mean arterial pressure and stroke volume index.
from start to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

February 2, 2024

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E2-23-3460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

fluid responsiveness

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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