Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Hierarchical composite endpoint, ordered by clinical priority
研究概览
简要总结
We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.
详细描述
This is a pragmatic, randomized controlled trial comparing OR extubation versus ICU extubation among adults undergoing elective cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass
- •Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator
- •Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon
- •Able to provide informed consent
排除标准
- •Underlying pulmonary disease requiring use of home supplemental oxygen
- •Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR > 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation
- •Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram
- •Obstructive sleep apnea with home CPAP or biPAP use or recommended use
- •Neuromuscular disease associated with respiratory muscle weakness including myasthenia gravis, Lambert-Eaton myasthenic syndrome, or muscular dystrophy
- •Airway abnormalities including tracheostomy, history of difficult mask ventilation, history of difficult intubation requiring fiberoptic rescue or multiple (>2) attempts, known anatomic abnormalities including limited mouth opening (< 3cm), severe micrognathia, tracheal stenosis, or tracheal compression due to mass or goiter
- •We will also exclude patients undergoing the following procedures:
- •Transplant surgery
- •Pulmonary thromboendarterectomy
- •Implantation of mechanical circulatory support including LVAD, Impella, intra-aortic balloon pump, RVAD, or ECMO
研究组 & 干预措施
ICU extubation
Extubation in the intensive care unit (ICU) within 6 hours of leaving the OR
干预措施: ICU extubation (Procedure)
OR extubation
Extubation in the operating room (OR) at the conclusion of cardiac surgery
干预措施: OR extubation (Procedure)
结局指标
主要结局
Hierarchical composite endpoint, ordered by clinical priority
时间窗: 15 days postoperatively
1. Death by postoperative day 15; 2. Unplanned reintubation or cumulative mechanical ventilation \> 12 hours from OR exit, assessed through 48 hours postoperatively; 3. Days at home through postoperative day 15 (DAH-15). DAH-15 will be measured from the time of post-operative ICU admission and will subtract any time spent in a hospital (index hospitalization or readmission), rehabilitation center, or nursing facility.
次要结局
- Postoperative ICU length of stay(30 days)
- Postoperative hospital length of stay(30 days)
- Use of non-invasive respiratory support(48 hours)
研究者
Lauren E Gibson
Cardiac anesthesiologist
Massachusetts General Hospital