NCT07044089

Brief Summary

Our aim in this study is to compare fixed and individualized PEEP (driving pressure guided ) application for intraoperative lung protective ventilation in patients undergoing on-pump CABG surgery. Researcher aimed to compare the effects of two different PEEP application methods on intraoperative hemodynamics, respiratory mechanics, and gas exchange, as well as postoperative extubation times, respiratory complications (atelectasis, need for non invasive mechanical ventilatıon, need for re-entubatıon) length of stay in the intensive care unit, and discharge times.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Jul 2025

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jul 2025Sep 2027

First Submitted

Initial submission to the registry

June 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

July 23, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

June 23, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

Lung Protective VentilationFixed PEEPIndividualized PEEP

Outcome Measures

Primary Outcomes (1)

  • Effects on intraoperative oxygenation, hemodynamics, lung compliance and airway pressures

    Data will be recorded during surgery and the first 24 hours after extubation.

    First one day

Study Arms (2)

Fixed PEEP

Indıvıdalızed PEEP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo elective on-pump coronary artery bypass graft surgery under general anesthesia

You may qualify if:

  • Patients scheduled for elective on-pump coronary artery bypass graft surgery via median sternotomy
  • Patients between the ages of 18 and 70
  • ASA (American Society of Anesthesiologists) physical status classification II-III

You may not qualify if:

  • Patients with an ejection fraction below 35%
  • Patients who did not consent to participate in the study
  • Patients undergoing emergency surgery
  • Patients who are allergic to the anesthetic drugs used
  • Patients who have undergone lung resection
  • Those with a history of mechanical ventilation in the 2 months before surgery
  • Patients who have undergone total circulatory arrest and deep hypothermia
  • Patients with obstructive sleep apnea syndrome requiring long-term ventilation assistance
  • Morbid obesity (Body Mass Index\>35kg/m2)
  • Patients with refractory hypoxemia (arterial oxygen saturation below 88% despite 100% oxygen inhalation)
  • COPD (FEV1\<70%)
  • Patients with chronic renal failure (serum creatine\>1.8 mg/dl)
  • Anemia (Hg\<10 gr/dl)
  • Patients who have had an intraaortic balloon pump placed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Faculty of Medicine

Kocaeli, izmit, 41100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Zeynep Açık, MD

CONTACT

Tülay Çardaközü, PROFESSOR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Doctor

Study Record Dates

First Submitted

June 23, 2025

First Posted

June 29, 2025

Study Start

July 23, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations