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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06249568
Other study ID # E2-23-3460
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date February 20, 2024

Study information

Verified date January 2024
Source Ankara City Hospital Bilkent
Contact meltem sakman yilmaz
Phone +90 505 922 1049
Email meltemsakmann@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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?


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date February 20, 2024
Est. primary completion date February 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility - 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Ankara Bilkent Sehir Hastanesi Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of fluid responsiveness in patients undergoing coronary arter bypass surgery. : 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
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