Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06108791 |
Other study ID # |
SSI32641 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2024 |
Est. completion date |
March 2025 |
Study information
Verified date |
October 2023 |
Source |
Assiut University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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
Description:
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.