NCT07189260招募中不适用
Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia in Patients Undergoing Hip Fracture Surgery
University Hospital Bispebjerg and Frederiksberg4 个研究点 分布在 1 个国家目标入组 566 人开始时间: 2024年2月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 566
- 试验地点
- 4
- 主要终点
- The incidence of hospital-acquired pneumonia
研究概览
简要总结
The goal of this clinical trial is to investigate whether pre- and postoperative treatment with systematic PEP therapy can prevent hospital-acquired pneumonia in patients with hip frac-ture. It will also learn about the barriers regarding PEP therapy in this group of patients.
- Does pre- and postoperative treatment with systematic PEP therapy prevent hospital-acquired pneumonia in patients with hip fracture?
- Which barriers do participants have regarding PEP therapy in this group of patients? Researchers will compare systematic PEP therapy to no intervention besides standard treat-ment to see if systematic therapy with PEP can prevent hospital-acquired pneumonia.
Participants will:
- Receive systematic PEP therapy during hospitalization or no intervention besides standard treatment
- Register the PEP therapy four times daily on a paper checklist. Failure to perform the treatment and the reason must also be documented on the checklist.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip fracture regardless of age
- •Cognitively well-functioning
- •Able to understand the study and give informed consent
- •Able to speak and understand Danish
- •Resident of Region Hovedstaden or Region Sjælland
排除标准
- •Cognitively impaired
- •Unable to understand the study and give informed consent
- •Pneumonia upon admission
- •Delirium upon admission
- •Pneumothorax
- •For patients with e.g. dementia or brain injury, the ability to give informed consent will be assessed individually.
结局指标
主要结局
The incidence of hospital-acquired pneumonia
时间窗: During hospitalization, from intervention start to discharge, which is on average one week
Primary Outcome is the incidence of hospital-acquired pneumonia in the control and intervention group. Documented in the Sundhedsplatformen and diagnosed with one ore more of the following: * Thoracic x-ray * Sputum culture * Auscultation * Infection markers
次要结局
- Number of participants dead within 30-days after discharge(30-day mortality, assessed 30 days after discharge from the orthopedic ward)
- Number of participants readmitted within 30-days after discharge(30-day readmission post-discharge, assessed 30 days after discharge from the orthopedic ward)
- Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.(During hospitalization, from intervention start to discharge, which is on average one week)
- Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission.(CAS the weeks up to hip fracture and CAS at discharge, which is on average one week after admission)
- Discharge destination (home, nursing home, care facility, rehab, another ward/hospital, etc.). Number of participants discharged to home, care facility, rehab, another hospital/ward or ot he discharge destination.(Assessed at discharge from the orthopedic department, which is on average one week efter admission)
研究者
Charlotte Densing
Project nurse
University Hospital Bispebjerg and Frederiksberg
研究点 (4)
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