Assessment of Cardiopulmonary Function in Response to Continuous Positive Airway Pressure in Patients With Severe Obesity After Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- End expiratory lung impedance
研究概览
简要总结
The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:
- Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?
- Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?
Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.
- Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure
- Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present).
详细描述
The current proposed crossover study is a single center, open-label clinical trial in patients who have severe obesity (defined by body mass index greater than or equal to 40 kg/m2) and are recovering from anesthesia. The primary aim is to describe the difference cardiopulmonary function between two settings for continuous positive airway pressure (CPAP), using electrical impedance tomography (EIT), transthoracic echocardiography, and esophageal pressure monitoring to measure response. The secondary aim is to determine whether the location of adipose tissue modifies responses to CPAP settings.
The study protocol consists of placing an esophageal catheter to monitor intrathoracic pressure in the operating room when the participant is under anesthesia. In the post-anesthesia care unit, participants will receive two CPAP settings, in random order, for 20 minutes each. One setting is a recruitment maneuver and CPAP set to the level of end-expiratory pressure (intrathoracic pressure). Another setting is a CPAP set to home levels (if known) or 8-10 cmH20 if not on home CPAP. There will be a 10 minute washout period between interventions. Investigators will monitor airway and esophageal pressure, ventilation with electrical impedance tomography, right heart function with transthoracic echocardiography, and abdominal muscle contraction with ultrasound. Waist and hip circumference will be measured prior to CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Adult patients (≥ 18 years old) scheduled for elective non-cardiothoracic surgery requiring general anesthesia with an endotracheal tube
- •Planned admission to the post-anesthesia care unit (PACU) after surgery
- •BMI ≥ 40 kg/m2
- •At the time of baseline measurements in the PACU, patients meet the following criteria:
- •Receiving ≤ 6 liters of supplemental nasal cannula oxygen
- •Alert as defined by a Richmond Agitation Sedation Scale of 0 or -1
- •Oriented to person, place, and time
排除标准
- •Pregnancy, suspected pregnancy or less than six weeks postpartum Known or current pneumothorax
- •Hemodynamic instability at the time of study assessment in the PACU defined as:
- •systolic blood pressure <90 mmHg or >180 mmHg
- •mean blood pressure <60 or >130 mmHg
- •Any use of intravenous vasoactive agent
- •heart rate < 50 or > 120 beats per minute
- •Respiratory insufficiency in PACU defined as:
- •Respiratory rate > 30
- •Oxygen saturation < 92%
- •Receiving > 6 liters of supplemental oxygen
- •Known chronic lung disease requiring supplemental oxygen at home
- •Known systolic heart dysfunction (left ventricular ejection fraction ≤ 30%)
- •Contraindication for esophageal catheter placement:
- •Known esophageal varices
- •Known bacterial sinusitis
- •Recent esophageal, nasopharyngeal, or laryngeal trauma or surgery
- •Known coagulopathy: including history of thrombocytopenia defined as platelet count <50,000; presence of hemophilia; known genetic disorder of coagulation (e.g.,deficits of protein C, protein S, von Willebrand factor) or oral and subcutaneous anticoagulation treatment (e.g., heparin, warfarin, and or other oral anticoagulants)
- •Contraindication for electrical impedance tomograph belt placement:
- •Pacemaker and/or internal cardiac defibrillator
- •Chest skin injury
- •Concern for study inclusion by the perioperative nurse or anesthesia team
研究组 & 干预措施
Recruitment and ITP-CPAP
Recruitment maneuver followed by CPAP set to intrathoracic pressure (ITP)
干预措施: Recruitment/ITP-CPAP (Intervention A) (Device)
Standard CPAP
CPAP set to home level of CPAP (if known) or CPAP set to standard levels (8-10 cmH20)
干预措施: Standard CPAP (Intervention B) (Device)
Atmospheric pressure
Breathing without CPAP
干预措施: Atmospheric Pressure (Device)
结局指标
主要结局
End expiratory lung impedance
时间窗: Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes)
End expiratory lung impedance, a surrogate of end expiratory lung volume, measured from EIT
次要结局
- Regional lung ventilation(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Systemic blood pressure(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Right ventricular function(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Mean pulmonary artery pressure(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Inspiratory effort(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Respiratory rate(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Oxygen saturation(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
- Abdominal muscle thickness(Assessed at baseline during atmospheric pressure breathing (no CPAP), assessed at the end of intervention A (20 minutes), assessed at end of intervention B (20 minutes))
研究者
Timothy G. Gaulton, MD
Member of the Faculty of Anesthesia
Massachusetts General Hospital