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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.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Medical therapy device |
|
| Standard treatment | No Intervention | Standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| positive expiratory pressure | Device | PEP therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hospital-acquired pneumonia | 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:
| During hospitalization, from intervention start to discharge, which is on average one week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants dead within 30-days after discharge | 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 |
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Inclusion Criteria:
Exclusion Criteria:
For patients with e.g. dementia or brain injury, the ability to give informed consent will be assessed individually.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg & Frederiksberg Hospital | Recruiting | Copenhagen | 2400 | Denmark |
Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D011014 | Pneumonia |
| D000077299 | Healthcare-Associated Pneumonia |
| D010024 | Osteoporosis |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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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. | 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. | Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission. CAS values ranges from 0 to 6. A score of 6 represents an independant patient in regards to getting in and out of bed, sit-to-stand from a chair, and walking. A score of 0 represents a patient completely dependant on help getting in and out of bed, sit-to-stand from a chair, and walking. | 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. | 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 o the discharge destination. | Assessed at discharge from the orthopedic department, which is on average one week efter admission |
| Herlev & Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
|
| D007869 |
| Leg Injuries |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003428 | Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |