Effect of Ultra-Low Tidal Volume on Mechanical Power During Heart Bypass Surgery
NCT07073885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-03-02
Summary
The goal of this clinical trial is to evaluate whether ultra-low tidal volume (ULTV) ventilation during cardiopulmonary bypass (CPB) can reduce mechanical power (MP) and improve postoperative respiratory outcomes in adult patients undergoing elective coronary artery bypass graft (CABG) surgery.
The main questions it aims to answer are:
Does ULTV ventilation during CPB result in lower intraoperative mechanical power compared to apnea?
Can ULTV ventilation reduce extubation time and ICU (Intensive Care Unit) stay and improve the PaO₂/FiO₂ ratio (Partial Pressure of Arterial Oxygen / Fraction of Inspired Oxygen Ratio)?
Researchers will compare patients receiving ULTV ventilation to those undergoing apnea after aortic cross-clamping to assess the effects on mechanical power and postoperative outcomes.
Participants will:
Be randomized to either ULTV ventilation or apnea group
Undergo standard general anesthesia and CABG surgery
Have mechanical power measured at three time points (pre-CPB, post-CPB, and ICU pre-extubation)
Have arterial blood gases evaluated for PaO₂/FiO₂ ratios
Be monitored for extubation time and ICU length of stay
This study aims to generate evidence that could inform safer and more protective intraoperative ventilation strategies during cardiac surgery.
Conditions
Interventions
- OTHER
-
Ultra-Low Tidal Volume Ventilation
Ventilation continued during CPB using volume-controlled mode with ultra-low tidal volume (3-4 mL/kg IBW(Ideal Body Weight)), 12-15 breaths/min, 5 cm H₂O PEEP, and 50% FiO₂.
- OTHER
-
Apnea Group
In this group, mechanical ventilation will be discontinued after aortic cross-clamping during CPB, and apnea will be maintained throughout the bypass period.
Sponsors & Collaborators
-
Konya City Hospital
lead OTHER
Principal Investigators
-
Esma karaarslan, MD · Konya City Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-10
- Primary Completion
- 2026-02-15
- Completion
- 2026-02-20
Countries
- Turkey (Türkiye)
Study Locations
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