高危腹部手术（PENGUIN）患者围手术期呼吸护理和预后：一项随机国际内部试点试验

BJA open Pub Date : 2025-04-10 DOI:10.1016/j.bjao.2025.100396

PENGUIN Trial Management Group

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引用次数: 0

摘要

背景感染是中低收入国家（LMICs）腹部手术的常见并发症。高浓度吸氧（FiO2）和洗必泰漱口水在预防术后感染方面的作用尚未得到证实。方法一项由国际结果评估师盲法、2x2 因式随机试验的内部试验阶段，试验对象是在低收入和中等收入国家医院接受中线开腹手术的年龄≥10 岁的患者。试验的主要目的是比较术前使用 0.2% 洗必泰漱口水预防肺炎与不使用漱口水的临床效果，以及围手术期使用 80-100% FiO2 预防手术部位感染 (SSI) 与使用 21-35% FiO2 的临床效果。这项为期 12 个月的内部试点评估了医院选址、患者招募、干预依从性、患者随访和安全性等方面的可行性。患者按1:1:1:1的比例随机分配到四个干预组组合中，并随访30天。其中有 907 名成人（97.8%）和 20 名十岁或以上的儿童（2.2%）：89/927（9.6%）名患者死亡。70% 的目标医院（7/10）开设了医疗点，107% 的医院招募了患者（927/870）。917/927（99%）名漱口水组患者和 840/927（91%）名氧气组患者接受了分配的干预措施。氧气干预的坚持率较低主要与临床上需要增加 FiO2 的 21-35% FiO2 组有关。924/927（99%）名患者的30天随访均已妥善完成，所有患者的随访均由一名蒙面评估员完成。结论这项试验表明，在低收入国家开展预防术后感染的大型 III 期试验具有可行性和安全性。试验注册ClinicalTrials.gov NCT04256798。

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PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial

Background

Infections are a common complication of abdominal surgery in low- and middle-income countries (LMICs). The role of a high fraction of inspired oxygen (FiO₂) and chlorhexidine mouthwash in preventing post-operative infections is unconfirmed.

Methods

Internal pilot phase of an international outcome assessor-blinded, 2x2 factorial randomised trial of patients aged ≥10-years undergoing midline laparotomy in LMIC hospitals. The main trial objectives are to compare the clinical effectiveness of preoperative 0.2% chlorhexidine mouthwash in preventing pneumonia versus no mouthwash, and 80–100% perioperative FiO₂ to prevent surgical site infection (SSI) versus 21–35% FiO₂. This 12-month internal pilot assessed feasibility of hospital site opening, patient recruitment, intervention adherence, patient follow-up and safety. Patients were randomised in a 1:1:1:1 ratio to the four intervention group combinations and followed up for 30 days.

Results

We recruited 927 patients from seven hospitals in India and South Africa over 12 months from November 2020. There were 907 adults (97.8%) and 20 children aged ten or over (2.2%): 89/927 (9.6%) patients died. Site opening reached 70% of our target (7/10) hospitals, and patient recruitment 107% (927/870). 917/927 (99%) patients in the mouthwash arm, and 840/927 (91%) patients in the oxygen arm received the allocated intervention. Lower adherence to the oxygen intervention related mainly to clinically necessary FiO₂ increases in the 21–35% FiO₂ arm. 30-day follow-up was completed appropriately for 924/927 (99%) patients. and was performed by a masked assessor for all patients. There were no reported safety events.