Supplemental perioperative oxygen and the risk of surgical wound infection -: A randomized controlled trial
Supplemental perioperative oxygen and the risk of surgical wound infection -: A randomized controlled trial
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DOI：
10.1001/jama.294.16.2035
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发表时间：
2005-10-26
影响因子：
120.7
通讯作者：
Ortí, R
中科院分区：
文献类型：
--
作者：
Belda, FJ;Aguilera, L;Ortí, R
背景：已有报道称围手术期补充氧可使手术伤口感染风险减半或加倍。目的验证补充氧可降低结直肠癌术后患者感染风险的假设。设计、环境和患者：2003年3月1日至2004年10月31日，西班牙14家医院的300名年龄在18岁至80岁之间的择期结肠直肠手术患者进行了一项双盲、随机对照试验。伤口感染由盲法调查人员根据疾病控制和预防中心的标准进行诊断。记录患者的基线特征、麻醉治疗和潜在的混杂因素。干预措施患者被随机分配到30%或80%吸氧（FIO2）分数的术中和术后6小时。麻醉治疗和抗生素给药标准化。手术部位感染（SSI）；次要结局包括肠功能恢复和耐受固体食物的能力、行走、拆除缝线和住院时间。结果143例患者围术期吸氧30%，148例患者围术期吸氧80%。30% FIO2组35例（24.4%）发生手术部位感染，80% FIO2组22例（14.9%）发生手术部位感染（P= 0.04）。与30% FIO2组相比，80% FIO2组SSI的风险降低39%（相对风险[RR]， 0.61； 95%可信区间[CI]， 0.38-0.98）。校正重要协变量后，给予补充氧的患者感染的RR为0.46 （95% Cl, 0.22-0.95； P= 0.04）。两个治疗组的次要结局均无显著差异。结论补充吸氧可显著降低患者伤口感染的风险。补充氧似乎是一种有效的干预措施，以减少SSI患者接受结肠或直肠手术。临床试验注册：ClinicalTrials.gov标识符：NCT00235456。
Context Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection,Objective To test the hypothesis that supplemental oxygen reduces infection risk in patients following colorectal surgery.Design, Setting, and Patients A double-blind, randomized controlled trial of 300 patients aged 18 to 80 years who underwent elective colorectal surgery in 14 Spanish hospitals from March 1, 2003, to October 31, 2004. Wound infections were diagnosed by blinded investigators using Centers for Disease Control and Prevention criteria. Baseline patient characteristics, anesthetic treatment, and potential confounding factors were recorded.Interventions Patients were randomly assigned to either 30% or 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.Main Outcome Measures Any surgical site infection (SSI); secondary outcomes included return of bowel function and ability to tolerate solid food, ambulation, suture removal, and duration of hospitalization.Results A total of 143 patients received 30% perioperative oxygen and 148 received 80% perioperative oxygen. Surgical site infection occurred in 35 patients (24.4%) administered 30% FIO2 and in 22 patients (14.9%) administered 80% FIO2 (P=.04). The risk of SSI was 39% lower in the 80% FIO2 group (relative risk [RR], 0.61; 95% confidence interval [CI], 0.38-0.98) vs the 30% FIO2 group. After adjustment for important covariates, the RR of infection in patients administered supplemental oxygen was 0.46 (95% Cl, 0.22-0.95; P=.04). None of the secondary outcomes varied significantly between the 2 treatment groups.Conclusions Patients receiving supplemental inspired oxygen had a significant reduction in the risk of wound infection. Supplemental oxygen appears to be an effective intervention to reduce SSI in patients undergoing colon or rectal surgery.Trial Registration ClinicalTrials.gov Identifier: NCT00235456.