PErioperative Respiratory Care and Outcomes for patieNts Undergoing hIgh Risk abdomiNal Surgery: A 2x2 Factorial, International Pragmatic Randomised Controlled Trial Across Low and Middle-income Countries
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12,942
- 试验地点
- 37
- 主要终点
- Number of participants with surgical site infection (Oxygen therapy intervention only)
研究概览
简要总结
PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery.
Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.
详细描述
PENGUIN is a pragmatic, blinded (outcome assessor), 2x2 factorial, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce surgical site infection (SSI) and pneumonia rates in patients undergoing surgery with an abdominal incision.
Pneumonia is one of the most serious complications to occur after surgery, accounting for up to one in four of all postoperative deaths. The incidence is greater still in high-risk populations such as those undergoing midline laparotomy where mortality rates are more than 10%. SSIs are clearly important being the most frequent healthcare-associated infection in LMICs, affecting one in three patients undergoing contaminated or dirty surgery (34, 35). SSIs cause pain, discomfort and disability. They increase the time taken to return to work, and healthcare costs
The risk of postoperative mortality and complications such as surgical site infection is three times greater in low and middle-income countries (LMICs) than in high-income countries. In order to address surgical need worldwide, it is estimated that provision of a further 312 million operations would be required each year.
Patients will be recruited from hospitals in Low and Middle Income Countries (LMICs) who are undergoing elective or emergency mid-line laparotomy. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:
A. Preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery B. No preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery C. Preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery D. No preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children aged 10 years or over
- •Elective or emergency abdominal surgery via midline laparotomy with an anticipated abdominal incision of at least 5cm in length
- •Written informed consent of patient (signature or a fingerprint)
排除标准
- •Patients undergoing caesarean section
- •Patients with a documented or suspected allergy to chlorhexidine
- •Patient unable to complete postoperative follow-up (not contactable after discharge)
- •Previous enrolment in PENGUIN within the past 30 days
- •American Society of Anesthesiologists (ASA) grade V patients (expected to die with or without surgery)
研究组 & 干预措施
Mouthwash and liberal oxygen during surgery
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery.
干预措施: Chlorhexidine mouthwash (Drug)
Mouthwash and liberal oxygen during surgery
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery.
干预措施: Oxygen (Drug)
No mouthwash and liberal oxygen during surgery
No pre-surgical mouthwash in combination with 80-100% FiO2 during surgery.
干预措施: Oxygen (Drug)
Mouthwash and restrictive oxygen during surgery
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery.
干预措施: Chlorhexidine mouthwash (Drug)
Mouthwash and restrictive oxygen during surgery
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery.
干预措施: Oxygen (Drug)
No mouthwash and restrictive oxygen during surgery
No pre-surgical mouthwash in combination with 21-30% FiO2 during surgery.
干预措施: Oxygen (Drug)
结局指标
主要结局
Number of participants with surgical site infection (Oxygen therapy intervention only)
时间窗: Within 30 days post-surgery from index operation
The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND The patient must have at least one of the following: * Purulent drainage from the wound * Organisms are detected from a wound swab * Wound opened spontaneously or by a clinician AND, fever (\>38°C), OR at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; * Diagnosis of SSI by a clinician or radiological imaging
Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only)
时间窗: Within 30 days post-surgery from index operation
Pneumonia will be classified using the US Centers for Disease Control (CDC) definition of pneumonia
次要结局
- Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions)(Within 30 days post-surgery from index operation)
- Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)(Within 30 days post-surgery from index operation)
- Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)(Within 30 days post-surgery from index operation)
- Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only)(Within 30 days post-surgery from index operation)
- Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions)(Within 30-days post surgery from index operation)
- Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions)(Within 30 days post-surgery from index operation)
- Health resource usage per patient(Within 30 days post-surgery from index operation)