Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery to Improve Post Operative Pulmonary Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time of mechanical ventilation
研究概览
简要总结
The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
详细描述
Obesity is an ongoing worldwide problem, and as such, weight-related issues arise especially in the intensive care unit (ICU). Morbid obesity adversely affects physiology; restricted thoracic movement and increased intra-abdominal pressure leads to reduced lung volumes and compliance resulting frequently in atelectasis, ventilation-perfusion mismatch.
Cardiac surgical patients are at particular risk for PPCs. The use of cardiopulmonary bypass (CPB) is responsible for a systemic inflammatory response and oxidative stress, leading to pulmonary ischemia-reperfusion injury. Mechanical ventilation frequently is disrupted during CPB, thus inducing atelectasis. Some proposed mechanisms are leukocyte activation, fluid accumulation in the lung and atelectasis.
Atelectasis is a highly prevalent pulmonary complication in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and an important cause of postoperative hypoxemia. Pulmonary collapse occurs early after the induction of anesthesia and persists for several days postoperatively. Studies based on thoracic computed tomography (CT) have shown that pulmonary collapse is mainly distributed to the dependent regions close to the diaphragm and may encompass up to 35% of the overall lung parenchyma which predispose to pneumonia.
This impairment of lung function, particularly oxygenation of the blood, is a common and potentially serious complication after cardiac surgery. It has been shown to persist for as long as one week after the operation.
In obese patients, the functional residual capacity (FRC) and lung compliance are reduced, and thus the elastic work of breathing (WOB) is elevated. By applying continuous positive airway pressure (CPAP), the FRC is restored, and inspiration starts from a more favorable pressure-volume relationship, facilitating spontaneous ventilation, and improves oxygenation.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 y.
- •Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
- •Class III Obesity (Morbid obesity): BMI ≥ 40.0 kg/m².
排除标准
- •Patients with obstructive lung disease (asthma or chronic obstructive pulmonary disease).
- •Pneumothorax or Surgical emphysema.
- •Mechanical ventilation prior to the operation.
- •Patient Refusal.
研究组 & 干预措施
APRV group
Group A: APRV group (30 Patients) Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15
- P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O
- T high at 4-6 seconds
- P low at 0
- T low at 0.5 to 0.8 seconds.
- ATC (automatic tube compensation) on.
- FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.
干预措施: Use Of APRV mode of Ventilation (Device)
Standard group
Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16
- Tidal Volume 6-8 ml/kg predicted body weight
- Respiratory rate (RR) 14 /min
- Positive end expiratory pressure (PEEP)= 5 cmH2o
- Pressure Support (PS) = 10 cmH2o
- Inspiratory time 1.4 Sec
- FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 %
干预措施: Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode (Device)
结局指标
主要结局
Time of mechanical ventilation
时间窗: up to 3 days
Hours of Mechanical ventilation
PO2/FIO2 (P/F) ratio
时间窗: up to 3 days
Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours
次要结局
- Occurrence Respiratory complications(up to 1 week)
- length of ICU stay(up to 3 days)
- Need for Non-Invasive ventilation (NIV)(up to 3 days)
- Need for Vasopressors and Inotropes(up to 1 day)
- length of Hospital stay(up to 10 days)
- Mortality(up to 30 days)
- Effect on Blood pressure(up to 1 day)
研究者
Mohamed Alaaeldin Abdelmoneem Alhadidy
Principal Investigator
Ain Shams University
