Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 7:07 AM
Study NCT ID:
NCT04731532
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'pulmonary department, physical therapy and rehabilitation, anesthesiology and reanimation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of patient waking from the mechanical ventilator', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'hour'}, {'measure': 'Measuring of chronic health assessment II (APACHE II) scores', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'score'}, {'measure': 'Determination of tidal volume', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mmHg'}, {'measure': 'Measuring of minute respiratory rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'counts / minute'}, {'measure': 'Determination of peak air pressure', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mmHg'}, {'measure': 'Determination of mean air pressure', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mmHg'}, {'measure': 'Measuring of blood lactate levels', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mmol/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory physiotherapy'], 'conditions': ['Pulmonary Medicine', 'Ventilators, Mechanical']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://doi.org/10.1016/j.aucc.2017.10.001', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Inclusion and Exclusion Criteria: Patients aged 18-65 years who are admitted to the investigator's 3rd Stage Intensive Care Unit and are dependent on mechanical ventilation will be included. The study was planned with 80 patients. Those with known chronic illnesses such as renal insufficiency, heart failure, liver failure, diabetes mellitus, hypertension, chronic obstructive pulmonary disease etc.,; patients in intensive care for postoperative follow-up; patients with mechanical ventilation due to chest or abdominal trauma will be excluded from the study.\n\nPatients who meet the study criteria will be evaluated by a physiotherapy and rehabilitation specialist and will be decided to be included in the respiratory physiotherapy program. The patients will be treated by two physiotherapists in the intensive care unit at random. One of the physiotherapists will perform classical respiratory physiotherapy with thoracic vibration and the other will only perform classical respiratory physiotherapy.\n\nPatients' acute physiology and chronic health assessment II (APACHE II) scores, partial oxygen pressure(PaO2) /fraction of inspired oxygen inspired oxygen fraction (FiO2), tidal volume, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels will be recorded daily. These values will be collected in the daily routine of the illness depending on the mechanical ventilation, by recording the already performed operations to follow the patient's clinic. If the duration of the total mechanical ventilation and complications occur, the type and timing of the complications will be examined.\n\nAt the end of the study, both physiotherapy methods, APACHE II scores, PaO2 / FiO2 values, tidal volume required, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels, mechanical ventilation duration and complications will be compared statistically."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who accepted for Step 3 Intensive Care Unit and connected to mechanical ventilation\n\nExclusion Criteria:\n\n* Patients with known chronic disease;\n* Patients in intensive care for postoperative follow-up;\n* Patients with mechanical ventilation due to chest or abdominal trauma'}, 'identificationModule': {'nctId': 'NCT04731532', 'briefTitle': 'Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'University of Health Sciences Bursa Yuksek Ihtisas Education and Training Hospital', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2018/04-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classical respiratory physiotherapy application', 'description': 'Patient positions, postural drainage application tapping and trifled', 'interventionNames': ['Procedure: classical respiratory physiotherapy with thoracic vibration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'classical respiratory physiotherapy with thoracic vibration', 'description': "Thoracic Vibration: The physiotherapist places his hands open with his / her fingers on the front and side walls of the patient's chest when the elbow is at 5-10 degrees of flexion. The elbow expands the patient's chest with vibrations. Exercise can be repeated 5-10 times a day+Patient positions, postural drainage application tapping and trifled", 'interventionNames': ['Procedure: classical respiratory physiotherapy with thoracic vibration']}], 'interventions': [{'name': 'classical respiratory physiotherapy with thoracic vibration', 'type': 'PROCEDURE', 'otherNames': ['classical respiratory physiotherapy'], 'description': 'Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .', 'armGroupLabels': ['Classical respiratory physiotherapy application', 'classical respiratory physiotherapy with thoracic vibration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16115', 'city': 'Bursa', 'state': 'Yıldırım', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Seyhan Dülger', 'role': 'CONTACT', 'email': 'drsdulger@gmail.com', 'phone': '05057482841'}], 'facility': 'Seyhan Dülger', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Seyhan Dülger,MD', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}