NCT06249568

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

January 13, 2024

Last Update Submit

July 15, 2024

Conditions

Keywords

fluid therapyCoronary Artery Bypass Surgery PatientsLung Recruitment Maneuver

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \. Be younger than 18 years old, be over 80 years old
  • \. Patients with an ASA score greater than 3
  • \. EF\<40%
  • \. Those with contraindications to anesthetic drugs
  • \. Patients with BMI\>30
  • \. Patients who did not want to participate in the study
  • \. Right ventricular dysfunction
  • \. COPD(Chronic obstructive pulmonary disease)
  • \. Bullous lung disease
  • \. Moderate to severe PHT
  • \. Severe kidney or liver disease
  • \. Patients with hemodynamic instability in the perioperative period
  • \. Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Central Study Contacts

meltem sakman yılmaz

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor

Study Record Dates

First Submitted

January 13, 2024

First Posted

February 8, 2024

Study Start

June 1, 2023

Primary Completion

August 2, 2024

Study Completion

August 20, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

fluid responsiveness

Locations