Clinical trial

Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery.

Opening soon · Not applicable · 0 countries · Registry ID NCT07409324

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionMorbid Obesity in Cardiac Surgery Patients, Postoperative Respiratory Dysfunction, Mechanical Ventilation Strategies

Full registry criteria

Inclusion Criteria: Adult patients aged 18-65 year of both sex. Morbidly obese patients (body mass index ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities) Scheduled for elective cardiac surgery (CABG, valve, or combined) requiring cardiopulmonary bypass Planned postoperative admission to the cardiac surgical intensive care unit Patients eligible for mechanical ventilation with planned early extubation within 6-12 hours postoperatively Ability to provide written informed consent Exclusion Criteria: Severe pulmonary disease (e.g., COPD GOLD III/IV, home oxygen therapy, and pulmonary fibrosis). Patients with history of previous spontaneous pneumothorax or postoperative pneumothorax. Intracranial hypertension or contraindication to APRV. Hemodynamically unstable on admission (MAP less than 65 mmHg) Vasopressor/inotropic score (VIS) more than 10 Requirement for postoperative extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP). Inability to obtain informed consent

Treatments and study arms

Airway Pressure Release Ventilation (APRV)

Device

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

Conventional Lung-Protective Mechanical Ventilation

Device

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.

Primary outcomes

Oxygenation Index (OI)o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation

The oxygenation index will be used as a quantitative measure of pulmonary oxygenation efficiency. It will be calculated using the formula: OI = (Mean Airway Pressure × FiO₂ × 100) / PaO₂. Changes in oxygenation index will be assessed to compare the effect of prophylactic APRV versus conventional lung-protective ventilation on pulmonary function in morbidly obese patients after elective cardiac surgery.

Study locations

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No public site location was included in this record. Check the original registry for updates.