Prophylactic Use of Airway Pressure Release Ventilation (APRV) Prior to Extubation in Morbidly Obese Patients Undergoing Elective Cardiac Surgery: Impact on Pulmonary Function, Oxygenation, and ICU Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Oxygenation Index (OI)
研究概览
简要总结
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.
详细描述
Morbid obesity is increasingly prevalent among patients undergoing elective cardiac surgery and is associated with significant postoperative respiratory morbidity. Reduced functional residual capacity, impaired chest wall compliance, atelectasis, and diaphragmatic dysfunction are further exacerbated by median sternotomy, cardiopulmonary bypass, and postoperative pain. These factors increase the risk of hypoxemia, difficult weaning from mechanical ventilation, extubation failure, and prolonged intensive care unit (ICU) stay in this high-risk population.
Conventional postoperative mechanical ventilation strategies in obese cardiac surgery patients typically rely on lung-protective volume-controlled ventilation with moderate to high positive end-expiratory pressure (PEEP). However, despite these strategies, postoperative atelectasis and impaired oxygenation remain common, particularly in morbidly obese patients.
Airway Pressure Release Ventilation (APRV) is a pressure-controlled mode of ventilation characterized by prolonged periods of high continuous airway pressure with brief release phases, allowing spontaneous breathing throughout the ventilatory cycle. APRV has been shown to improve alveolar recruitment, ventilation-perfusion matching, and oxygenation while limiting alveolar collapse and reducing atelectrauma. Its physiological advantages suggest a potential role in preventing postoperative pulmonary complications when applied early in the ICU course.
This randomized controlled study aims to evaluate the prophylactic application of APRV initiated upon ICU admission, compared with conventional lung-protective mechanical ventilation, in morbidly obese patients undergoing elective cardiac surgery. Mechanical ventilation will be applied according to group allocation until patients meet predefined criteria for extubation. Prior to extubation, both groups will be transitioned to standardized spontaneous breathing trials using continuous positive airway pressure (CPAP) or pressure support ventilation.
The primary outcome of the study is oxygenation index measured at predefined time points, including on ICU admission, immediately prior to extubation, and after extubation. Secondary outcomes include lung ultrasound score, incidence of reintubation, duration of mechanical ventilation, ICU length of stay, postoperative pulmonary complications, and hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
APRV Ventilation Strategy Group
Intervention Name: Airway Pressure Release Ventilation (APRV) Patients will receive airway pressure release ventilation immediately upon admission to the intensive care unit following elective cardiac surgery. APRV will be applied as the primary ventilatory mode until the patient fulfills predefined extubation readiness criteria. Prior to extubation, patients will be transitioned to continuous positive airway pressure (CPAP) with pressure support or a T-piece trial for 15-30 minutes according to ICU protocol.
干预措施: Airway Pressure Release Ventilation (APRV) (Device)
Conventional Lung-Protective Ventilation Group
Patients will receive conventional lung-protective mechanical ventilation using synchronized intermittent mandatory ventilation (SIMV) in volume-controlled mode with a tidal volume of 6-8 mL/kg of ideal body weight and high positive end-expiratory pressure upon admission to the intensive care unit. Ventilation will be continued until extubation readiness criteria are met, followed by a CPAP with pressure support or T-piece trial for 15-30 minutes prior to extubation.
干预措施: Conventional Lung-Protective Mechanical Ventilation (Device)
结局指标
主要结局
Oxygenation Index (OI)
时间窗: 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.
次要结局
- Lung Ultrasound Score (LUS)(o 1 hour before extubation o 6 hours post extubation)
- PaO₂/FiO₂ Ratio(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)
- Reintubation Rate(Within 48 hours after extubation)
- Duration of Mechanical Ventilation(From ICU admission until successful extubation, assessed up to 24 hours)
- Incidence of Post-Extubation Pulmonary Complications(Within 48 hours post-extubation)
- Number of Participants Requiring Vasopressor or Inotropic Support During APRV(From APRV initiation until 24 hours post-extubation)
- Mean Arterial Pressure During and After APRV(Immediately before APRV initiation 1 hour before extubation 1 hour post-extubation 3 hours post-extubation 6 hours post-extubation 24 hours post-extubation)