Associations of Intraoperative Hypocapnia With Patient Demographics, Ventilation Characteristics and Outcomes--Statistical Analysis Plan for an Individual Patient Data Analysis of PROVHILO and PROBESE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,793
- 试验地点
- 4
- 主要终点
- Incidence of postoperative pulmonary complications
研究概览
简要总结
To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation, the 'PROtective Ventilation using High versus LOw PEEP trial' (PROVHILO), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE).
详细描述
Lung-protective intraoperative ventilation (LPV) has the potential to improve the outcome of surgery patients through a reduction in postoperative pulmonary complications. Use of intraoperative ventilation strategies that use a low tidal volume could result in intraoperative hypercapnia. However, hypocapnia remains surprisingly common during intraoperative ventilation, possibly meaning that anesthesiologists continue to use high, if not too high respiratory rates or tidal volumes.
Previous studies suggested associations between intraoperative derangement of end-tidal carbon dioxide (etCO2) and postoperative outcomes. Indeed, two studies in highly selected patient groups showed associations of intraoperative hypocapnia with prolonged length of hospital stay, in patients undergoing pancreaticoduodenectomy, and in patients undergoing hysterectomy.
To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation; PROVHILO and PROBESE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Planned for major (abdominal) surgery.
- •At risk for postoperative pulmonary complications.
排除标准
- •Planned thoracic surgery or neurosurgery.
- •Unscheduled surgery (i.e., urgent, or emergent surgeries) were excluded because these patients may have had metabolic abnormalities at the moment of surgery, i.e., metabolic acidosis, for which the anesthesiologist may have adjusted the intraoperative ventilator settings. This may have led to a 'compensatory' low etCO
- •Patients with etCO2 recordings are missing from the study databases.
结局指标
主要结局
Incidence of postoperative pulmonary complications
时间窗: Until day seven or hospital discharge, whichever comes first
Composite of predefined and collected postoperative pulmonary complications. Postoperative pulmonary complications included mild, moderate, and severe respiratory failure; acute respiratory distress syndrome; bronchospasm; new pulmonary infiltrate; pulmonary infection; aspiration pneumonitis; pleural effusions; atelectasis; cardiopulmonary edema; and pneumothorax.
次要结局
- Incidence of intraoperative complications(Intraoperatively)
- Incidence of intensive care unit admission(Until hospital discharge, death or 100 days, whichever comes first)
- Incidence of extrapulmonary pulmonary complications(Until day seven or hospital discharge, whichever comes first)
- Incidence of 7-day mortality(Mortality during the first seven days of hospitalization)
- Incidence of in-hospital mortality(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 days)
- Incidence of major postoperative complications(Until day seven or hospital discharge, whichever comes first)
研究者
Prashant Nasa
Head of the Department, Critical Care Medicine
NMC Specialty Hospital