Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-22 @ 4:54 PM
Study NCT ID:
NCT04548466
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Positive Expiratory Pressure on the Management of Chest Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-11', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aid secretion clearance', 'timeFrame': '1 month', 'description': 'To determine if PEP bottle improves the secretion clearance'}], 'secondaryOutcomes': [{'measure': 'Resolution of pleural lesions', 'timeFrame': '1 month', 'description': 'To analysed if PEP bottle allows faster resolution of pleural lesions'}, {'measure': 'Improve lung function', 'timeFrame': '1 month', 'description': 'To determine if PEP bottle improves lung function tests'}, {'measure': 'Reduce hospital stay', 'timeFrame': '1 month', 'description': 'To assess if PEP bottle decreased hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Fracture']}, 'referencesModule': {'references': [{'pmid': '32417043', 'type': 'BACKGROUND', 'citation': 'Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20.'}, {'pmid': '31856165', 'type': 'BACKGROUND', 'citation': 'Liebsch C, Seiffert T, Vlcek M, Beer M, Huber-Lang M, Wilke HJ. Patterns of serial rib fractures after blunt chest trauma: An analysis of 380 cases. PLoS One. 2019 Dec 19;14(12):e0224105. doi: 10.1371/journal.pone.0224105. eCollection 2019.'}, {'pmid': '30940753', 'type': 'BACKGROUND', 'citation': 'Ingoe HM, Coleman E, Eardley W, Rangan A, Hewitt C, McDaid C. Systematic review of systematic reviews for effectiveness of internal fixation for flail chest and rib fractures in adults. BMJ Open. 2019 Apr 1;9(4):e023444. doi: 10.1136/bmjopen-2018-023444.'}, {'pmid': '29766081', 'type': 'BACKGROUND', 'citation': 'Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.'}, {'pmid': '15843697', 'type': 'BACKGROUND', 'citation': 'Gunduz M, Unlugenc H, Ozalevli M, Inanoglu K, Akman H. A comparative study of continuous positive airway pressure (CPAP) and intermittent positive pressure ventilation (IPPV) in patients with flail chest. Emerg Med J. 2005 May;22(5):325-9. doi: 10.1136/emj.2004.019786.'}, {'pmid': '17650355', 'type': 'BACKGROUND', 'citation': 'Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.'}]}, 'descriptionModule': {'briefSummary': 'Chest trauma (CT) are a common problem in our environment caused mainly by traffic accidents and causal and domestic accidents among the elderly population. CTs, in some situations, can lead to sequelae such as fibrothorax secondary to hemothorax and / or empyema and residual chronic pain. Clinical regulations and guidelines recommend a guideline for chest physiotherapy (CP) for all patients with rib fractures, but there is little scientific evidence. It would be interesting to establish CP treatment protocols and describe the most appropriate techniques according to the type and stages of thoracic trauma consolidation.\n\nObjective: To evaluate the effect of Positive Expiratory Pressure (PEP) breathing added to conventional CP in terms of aid secretion clearance, pain control, pleuropulmonary radiological abnormalities, restoration of lung function, and admission days in the immediate phase of the CT.', 'detailedDescription': 'After acceptance to participate in the study, patients will be computerized randomized into 2 groups:\n\n* PEP group: positive expiratory pressure breathing.\n* CONTROL group: conventional CP treatment without positive pressure brething. The period between day 0 and 20 days post-trauma is considered an immediate phase of CT.\n\nOnce admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary complications, the presence of respiratory failure, and pain control will be evaluated. The chest physiotherapist will perform a clinical and secretion assessment using the Seva test and a dynamic costal examination. The medical treatment of pain control will begin, and the treatment of CP will begin, where it will be randomized in 2 groups: 1- PEP group: positive expiratory pressure breathing with the help of a PEP bottle device. 2-CONTROL group: conventional CP treatment without positive pressure breathing will be daily FR sessions, on weekdays. Upon admission, hospital discharge and post-discharge, radiological checks (simple radiography) will be performed and forced vital capacity will be measured with forced spirometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest trauma with three or more rib fractures with or without hemopneumothorax\n* Failure to meet any exclusion criteria\n\nExclusion Criteria:\n\n* Non-cooperative patients for not understanding chest physiotherapy techniques.\n* Presence of respiratory failure on admission: PaO2 \\<60mmHg i / or PaCO2\\> 50mmHg.\n* Medical indication for mechanical ventilation or non-invasive ventilatory support.\n* Presence of undrained pneumothorax.\n* Complications that limit early mobility.'}, 'identificationModule': {'nctId': 'NCT04548466', 'briefTitle': 'Effect of Positive Expiratory Pressure on the Management of Chest Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Granollers'}, 'officialTitle': 'Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CT-positive expiratory'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CONTROL group', 'description': 'Chest physiotherapy depending on the location of the ribs fractures techniques are performed: 1. Postural control techniques; 2. Airways clearance techniques; 3. Breathing exercise (diaphragmatic breathing). 4. Early mobilization.'}, {'type': 'EXPERIMENTAL', 'label': 'PEP group', 'description': 'Chest physiotherapy depending on the location of the ribs fractures techniques are performed: 1. Postural control techniques; 2. Airways clearance techniques; 3. Breathing exercise (diaphragmatic breathing). 4. Early mobilization. 5. Positive expiratory pressure breathing (PEP bottle)', 'interventionNames': ['Device: PEP bottle']}], 'interventions': [{'name': 'PEP bottle', 'type': 'DEVICE', 'armGroupLabels': ['PEP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08553', 'city': 'Seva', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Inmaculada Castillo', 'geoPoint': {'lat': 41.83831, 'lon': 2.28007}}], 'overallOfficials': [{'name': 'Gemma Molist', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Granollers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Granollers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}