Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT07189260
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 566}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of hospital-acquired pneumonia', 'timeFrame': 'During hospitalization, from intervention start to discharge, which is on average one week', 'description': '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:\n\n* Thoracic x-ray\n* Sputum culture\n* Auscultation\n* Infection markers'}], 'secondaryOutcomes': [{'measure': 'Number of participants dead within 30-days after discharge', 'timeFrame': '30-day mortality, assessed 30 days after discharge from the orthopedic ward', 'description': 'Number of participants dead within 30 days after discharge'}, {'measure': 'Number of participants readmitted within 30-days after discharge', 'timeFrame': '30-day readmission post-discharge, assessed 30 days after discharge from the orthopedic ward', 'description': 'Number of participants readmitted within 30 days after discharge'}, {'measure': 'Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.', 'timeFrame': 'During hospitalization, from intervention start to discharge, which is on average one week', 'description': 'Incidence of delirium during hospitalization (journal entry, CAM-screening, diagnosis), up to 4 weeks.'}, {'measure': 'Degree of regained basic mobility (Cumulated Ambulation Score - CAS) on the the day of discharge compared to the assement made at admission.', 'timeFrame': 'CAS the weeks up to hip fracture and CAS at discharge, which is on average one week after admission', 'description': '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.'}, {'measure': '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.', 'timeFrame': 'Assessed at discharge from the orthopedic department, which is on average one week efter admission', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip fracture', 'pneumonia', 'PEP therapy', 'positive expiratory pressure', 'RCT', 'hospital-acquired pneumonia', 'systematic treatment with PEP', 'osteoporosis', 'frailty', 'multimorbidity'], 'conditions': ['Hip Fractures (ICD-10 72.01-72.2)']}, 'descriptionModule': {'briefSummary': '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.\n\n* Does pre- and postoperative treatment with systematic PEP therapy prevent hospital-acquired pneumonia in patients with hip fracture?\n* 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.\n\nParticipants will:\n\n* Receive systematic PEP therapy during hospitalization or no intervention besides standard treatment\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hip fracture regardless of age\n* Cognitively well-functioning\n* Able to understand the study and give informed consent\n* Able to speak and understand Danish\n* Resident of Region Hovedstaden or Region Sjælland\n\nExclusion Criteria:\n\n* Cognitively impaired\n* Unable to understand the study and give informed consent\n* Pneumonia upon admission\n* Delirium upon admission\n* Pneumothorax\n\nFor patients with e.g. dementia or brain injury, the ability to give informed consent will be assessed individually.'}, 'identificationModule': {'nctId': 'NCT07189260', 'briefTitle': 'Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bispebjerg and Frederiksberg'}, 'officialTitle': 'Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia in Patients Undergoing Hip Fracture Surgery', 'orgStudyIdInfo': {'id': 'PEP trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Medical therapy device', 'interventionNames': ['Device: positive expiratory pressure']}, {'type': 'NO_INTERVENTION', 'label': 'Standard treatment', 'description': 'Standard treatment'}], 'interventions': [{'name': 'positive expiratory pressure', 'type': 'DEVICE', 'description': 'PEP therapy', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ditte Stensgaard Andreasen', 'role': 'CONTACT', 'email': 'ditte.stensgaard.andreasen@regionh.dk', 'phone': '+4521283123'}, {'name': 'Charlotte Densing Petersen', 'role': 'CONTACT', 'email': 'charlotte.densing.petersen.01@regionh.dk'}, {'name': 'Ditte Stensgaard Andreasen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charlotte Densing Petersen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bispebjerg & Frederiksberg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Camilla Paaske', 'role': 'CONTACT', 'email': 'camilla.paaske@regionh.dk', 'phone': '+4538689682'}, {'name': 'Camilla Paaske', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Herlev & Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project nurse', 'investigatorFullName': 'Charlotte Densing', 'investigatorAffiliation': 'University Hospital Bispebjerg and Frederiksberg'}}}}