Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery.
NCT07409324 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2026-02-13
Summary
Morbidly obese patients undergoing open heart surgery are at increased risk of breathing problems after removal of the breathing tube due to reduced lung function and chest wall restriction following surgery. These complications may result in poor oxygenation, respiratory failure, and prolonged ICU stay.
Airway Pressure Release Ventilation (APRV) is a mechanical ventilation mode that improves lung recruitment and oxygenation. This study aims to evaluate whether the prophylactic use of APRV after ICU admission, compared with conventional lung-protective mechanical ventilation, improves oxygenation, lung function, and ICU outcomes in morbidly obese patients undergoing elective cardiac surgery.
Patients will be randomly assigned to receive either APRV or conventional ventilation during postoperative mechanical ventilation, followed by standard weaning and extubation. Outcomes include oxygenation index, lung ultrasound findings, need for reintubation, and ICU clinical outcomes.
Conditions
- Morbid Obesity in Cardiac Surgery Patients
- Postoperative Respiratory Dysfunction
- Mechanical Ventilation Strategies
Interventions
- DEVICE
-
Airway Pressure Release Ventilation (APRV)
Patients will be ventilated using the Airway Pressure Release Ventilation (APRV) mode immediately upon ICU admission. This mode will be maintained throughout the postoperative period until the patient meets the clinical criteria for extubation. with the following standardized steps: Initial APRV Settings * P High: 20-25 cm H₂O * P Low: 0 cm H₂O * T High: 4.0-6.0 seconds * T Low: 0.5-0.8 seconds * FiO₂: Adjusted to maintain SpO₂ \>92% Note: P High may be titrated according to patient tolerance, Mean airway pressure (MAP), and plateau pressures. T Low is set to terminate expiratory flow at 50-75% to preserve lung recruitment. Weaning/Transition from APRV to Extubation Once oxygenation and ventilation criteria are met: * T High will be gradually increased (to ≥8 sec) and P High decreased (to 10-15 cm H₂O) * Then transition to CPAP/PS for 15-30 minutes Final decision for extubation will be based on successful spontaneous breathing trial (SBT) (RSBI \< 105) and clinical readiness
- DEVICE
-
Conventional Lung-Protective Mechanical Ventilation
Patients will be ventilated using the SIMV Volume-Controlled mode with lung-protective strategies: * Tidal volume: 6-8 mL/kg of Ideal Body Weight (IBW) * PEEP: Set at 8-12 cm H₂O, individualized based on oxygenation status * Respiratory rate: Adjusted to maintain normocapnia, typically starting from 12-18 breaths per minute * FiO₂: Titrated to maintain SpO₂ \> 92% * Also transition to CPAP/PS for 15-30 minutes as a transition before extubation will be applied.
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Principal Investigators
-
Aya M Abbas, M.B.B.CH., M.Sc · Ain Shams University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2026-10-31
- Completion
- 2026-11-30
More Related Trials
-
Effect of Airway Pressure Release Ventilation on Right Ventricular Function Assessed by Transthoracic Echocardiography
NCT05414110 ·Status: UNKNOWN
-
Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).
NCT02866513 ·Status: COMPLETED ·Phase: NA
-
Comparative Study Between Airway Pressure Release Ventilation and Pressure Regulated Volume Control (PRVC) in Protective Lung Strategy as a Recruitment Maneuver for Severe ARDS Mechanically Ventilated Patients Using Lung Ultrasound Score
NCT07231107 ·Status: COMPLETED ·Phase: NA
-
Preventive Versus Curative Treatment of Fluid Overload
NCT04050007 ·Status: RECRUITING ·Phase: NA
-
The Effect of Preemptive APRV on Patients With High Risk for ARDS
NCT04699513 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS
NCT04386369 ·Status: COMPLETED
-
Physiological Effects of APRVplus and TCAV in ARDS
NCT06748807 ·Status: COMPLETED ·Phase: NA
-
Positive Expiratory Pressure With Blow-bottle Device Versus EPAP After Postoperative Cardiac Surgery
NCT03639974 ·Status: COMPLETED ·Phase: NA
-
Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation
NCT00793013 ·Status: WITHDRAWN ·Phase: PHASE2
-
Airway Pressure Release Ventilation as a Preventative Strategy
NCT00813371 ·Status: WITHDRAWN ·Phase: NA
-
Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients
NCT03202641 ·Status: TERMINATED ·Phase: NA
-
Intra-Operative Modified Ventilator Mechanical Power in Laparoscopic Bariatric Surgeries
NCT07065370 ·Status: COMPLETED ·Phase: NA
-
Intensive Alveolar Recruitment Protocol After Cardiac Surgery
NCT01502332 ·Status: COMPLETED ·Phase: NA
-
Effect of APRV vs. LTV on Right Heart Function in ARDS Patients: a Single-center Randomized Controlled Study
NCT05922631 ·Status: COMPLETED ·Phase: NA
-
Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery
NCT06117748 ·Status: RECRUITING ·Phase: NA
-
Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery
NCT07199881 ·Status: RECRUITING ·Phase: NA
-
CPAP in Patients With Severe Obesity After Anesthesia
NCT06287632 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation
NCT00224653 ·Status: COMPLETED ·Phase: NA
-
Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient
NCT00538161 ·Status: COMPLETED ·Phase: NA
-
Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS
NCT05767125 ·Status: UNKNOWN ·Phase: NA
-
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
NCT01204281 ·Status: COMPLETED ·Phase: PHASE4
-
Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery
NCT02633423 ·Status: UNKNOWN ·Phase: NA
-
Compare Airway Pressure Release Ventilation (APRV) to Conventional Mechanical Ventila
NCT07111039 ·Status: WITHDRAWN ·Phase: NA
-
Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery
NCT03098524 ·Status: COMPLETED ·Phase: NA
-
Physiological Dead Space Measured by Volumetric Capnography in BiPAP and APRV .
NCT03218943 ·Status: UNKNOWN ·Phase: NA