Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia

Официальное название

Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia in Patients Undergoing Hip Fracture Surgery

Обзор

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.

Вмешательства

• Устройство positive expiratory pressure
  PEP therapy

Первичные конечные точки

• The incidence of hospital-acquired pneumonia [Срок оценки: During hospitalization, from intervention start to discharge, which is on average one week]

Вторичные конечные точки (5)

• Number of participants dead within 30-days after discharge [Срок оценки: 30-day mortality, assessed 30 days after discharge from the orthopedic ward]
• Number of participants readmitted within 30-days after discharge [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Assessed at discharge from the orthopedic department, which is on average one week efter admission]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 2 центра

• Bispebjerg & Frederiksberg Hospital — Copenhagen
• Herlev & Gentofte Hospital — Herlev

Идентификаторы

NCT: NCT07189260 · PEP trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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