Domain-Specific Appendix: OXYGEN
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 7,800
- 试验地点
- 3
- 主要终点
- Surgical Site Infection
研究概览
简要总结
Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective 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
- Triple (Participant, Investigator, 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
- •PROMPT - Inclusion Criteria:
- •Adult patient (≥18 years of age at time of admission)
- •Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).
排除标准
- •ASA physical status 5 (moribund, not expected to survive with or without an operation)
- •Inability to provide informed consent
- •Previous participation in PROMPT within the prior 30 days.
- •DSA 02 - PROMPT - Exclusion Criteria:
- •ASA physical status 1 or 2
- •Undergoing cardiac surgery
- •Undergoing thoracic surgery if one-lung ventilation is required
- •Currently suspected or proven infection
- •Advanced lung disease requiring home oxygen therapy
- •Previous bleomycin therapy
- •Known or suspected pregnancy
研究组 & 干预措施
Liberal inspired oxygen
FiO2 0.8; i.e. 80%
干预措施: Liberal inspired oxygen (Drug)
Conservative inspired oxygen
FiO2 ≤0.3 [30%]
干预措施: Conservative inspired oxygen (Drug)
Intermediate inspired oxygen
FiO2 0.5 [50%]
干预措施: Intermediate inspired oxygen (Drug)
结局指标
主要结局
Surgical Site Infection
时间窗: 30 days
A post operative infection that develops at the site of an operation, caused by bacteria entering the body through the surgical incision
次要结局
- Quality of recovery(3 and 30 days after surgery)
- Mortality(30 days)
- EQ-5D-5L(30 days)
- DAH 30(30 days)
- Quality of recovery(3 and 30 days after surgery)
- Mortality(30 days)
- EQ-5D-5L(30 days)
- Health Care Associated Infections(30 days)
- DAH 30(30 days)
- major postoperative complications(30 days)