Effect of Ultra-Low Tidal Volume on Mechanical Power During Heart Bypass Surgery
NCT ID: NCT07073885
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-10-10
2026-01-15
Brief Summary
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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.
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Detailed Description
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After obtaining informed consent, eligible adult patients (ASA II-IV) scheduled for elective CABG will be randomly assigned to one of two groups:
ULTV Group: Ventilation will be continued after aortic cross-clamping using volume-controlled ventilation with a tidal volume of 3-4 mL/kg ideal body weight, 12-14 breaths per minute, 5 cm H₂O PEEP, and 50% FiO₂.
Apnea Group: Mechanical ventilation will be discontinued after aortic cross-clamping, and patients will remain apneic during CPB.
Mechanical power will be calculated using a validated surrogate formula and measured at three key time points: pre-CPB (baseline), post-CPB (before ICU transfer), and at the 3rd postoperative hour in the ICU (before extubation). Arterial blood gases will be obtained to determine PaO₂/FiO₂ ratios at these time points and 24 hours post-extubation.
Secondary outcomes include extubation time and length of ICU stay.
This study aims to generate evidence supporting the potential protective effects of continued low-volume ventilation during CPB, with a focus on reducing ventilator-induced lung injury by limiting mechanical power and preserving alveolar integrity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group ULTV
Participants in this group will continue to receive mechanical ventilation after aortic cross-clamping during cardiopulmonary bypass (CPB). Ventilation will be provided in volume-controlled mode with a tidal volume of 3-4 mL/kg ideal body weight, respiratory rate of 12-14 breaths/min, 5 cm H₂O PEEP (Positive End-Expiratory Pressure), and 50% FiO₂.
.
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)), 12-14 breaths/min, 5 cm H₂O PEEP, and 50% FiO₂.
Apnea Group
After the application of the aortic cross-clamp, mechanical ventilation will be discontinued, and apnea will be maintained.
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.
Interventions
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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)), 12-14 breaths/min, 5 cm H₂O PEEP, and 50% FiO₂.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients classified as ASA II-IV
* Patients scheduled for elective CABG
Exclusion Criteria
* Uncontrolled bronchial asthma
* Decompensated heart failure (NYHA class III-IV)
* Pulmonary hypertension
* History of lung surgery
* Morbid obesity (BMI \>35)
* Emergency surgery cases
* Patients who decline to participate in the study
18 Years
ALL
No
Sponsors
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Konya City Hospital
OTHER
Responsible Party
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Esma Karaarslan
Medical Doctor (MD), Department of Anesthesiology and Reanimation, Konya City Hospital
Principal Investigators
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Esma karaarslan, MD
Role: PRINCIPAL_INVESTIGATOR
Konya City Hospital
Locations
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Konya City Hospital
Konya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CABGO-MP
Identifier Type: -
Identifier Source: org_study_id
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