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临床试验/NCT06108791
NCT06108791已完成不适用

High vs Low Inspired Intraoperative Oxygen Concentration on the Incidence of Surgical Site Infection in Hepatobiliary Surgeries

Assiut University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2025年4月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
1
主要终点
Incidence of SSI

研究概览

简要总结

Surgical site infections (SSI) are the most common healthcare-associated infections and sources of morbidity and over-mortality. Factors that have been proven to reduce SSI include antimicrobial prophylaxis, maintenance of perioperative normothermia, avoidance of hyperglycemia, proper surgical techniques, and adequate pain relief postoperatively

详细描述

In 2016, a systematic review and meta-analysis assessing the effects of systematic high FiO2 (80%) compared with standard FiO2 (30%) concluded that high FiO2 was associated with a reduction of SSI in patients undergoing surgery under general anesthesia. Consequently, the WHO recommended that "adult patients undergoing general anesthesia should receive an 80% FiO2 intra-operatively to reduce the risk of SSI".These recommendations have sparked a large debate on the benefits and harms of hyperoxemia. From the theoretical point-of-view, several pro (prevention of hypoxemia, SSI, and postoperative nausea and vomiting) and con (respiratory adverse events, increased production of harmful "reactive oxygen species") arguments have been raised by believers and detractors of high FiO2. Accordingly, and despite these recommendations, anesthetists still used a wide range of intraoperative FiO2 in daily practice and frequently changed FiO2 settings during surgery unrelated to patients' PaO2 or SpO2.

The PROXI study, the largest multicenter randomized controlled trial specifically designed to assess the role of high vs. low intraoperative FiO2 on SSI, did not report any reduction of the incidence of SSI with the administration of 80% FiO2 during colorectal surgery. Similarly, the recent multicenter randomized iPROVE-O2 trial that included 740 patients undergoing major abdominal surgery, ventilated intraoperatively with an evidence-based protective strategy, reported a similar SSI rate between the 30% and 80% FiO2 groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - BMI of <35 kg/m2
  • scheduled for elective abdominal laparotomy/ laparoscopy under general anesthesia with an expected surgical time longer than 2 h.
  • ASA I and II

排除标准

  • - Patients undergoing minor procedures, where the expected duration of surgery will be less than 1 hour.
  • emergency surgeries for bowel obstruction.
  • abdominal surgery for vascular or plastic indications.
  • patients with a recent history of fever,
  • patients with uncontrolled diabetes mellitus,
  • patient with known immunological dysfunction (on steroids, decompensated liver disease, HIV, etc.).

研究组 & 干预措施

HIGH FIO2

Active Comparator

will include 50 patients: each one will receive intraoperatively a high concentration of oxygen (80% oxygen + 20% air), following extubation, high-concentration oxygen supplementation will be maintained and given through non-rebreathing face mask with a reservoir at 10 L/min for 2 h.

干预措施: FIO2=0.8 (Drug)

LOW FIO2

Placebo Comparator

will include 50 patients: each one will receive intraoperatively standard concentration oxygen (33% oxygen + 66% air) followed by oxygen supplementation through the standard Venturi face mask of 30%

干预措施: FIO2=0.33 (Drug)

结局指标

主要结局

Incidence of SSI

时间窗: 30 DAYS

\- the incidence of SSI postoperatively according to the Centers for Disease Control (CDC) criteria up to 30 days

次要结局

  • Pulmonary complications(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Abbas Hassan

lecturer

Assiut University

研究点 (1)

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