Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-06 @ 10:12 AM
Study NCT ID:
NCT02645695
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Effective Pulmonary Physiotherapy Method in Critically Care Patients?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-01', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-01-01', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline of Lung Collapse Index (LCI) values were recorded by listening both the lungs and scoring between 0 and 4 (0: normal expansion, 1: single lobe collapse, 2: 2 lobe collapse, 3: multiple lobe collapse) at six month', 'timeFrame': 'six month'}], 'secondaryOutcomes': [{'measure': 'weight of the dry sputum after six month', 'timeFrame': 'six month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Rehabilitation', 'Chest Physiotherapy', 'High Frequency Chest Wall Oscillation'], 'conditions': ['Atelectasis']}, 'referencesModule': {'references': [{'pmid': '23455861', 'type': 'BACKGROUND', 'citation': 'Esguerra-Gonzalez A, Ilagan-Honorio M, Fraschilla S, Kehoe P, Lee AJ, Marcarian T, Mayol-Ngo K, Miller PS, Onga J, Rodman B, Ross D, Sommer S, Takayanagi S, Toyama J, Villamor F, Weigt SS, Gawlinski A. CNE article: pain after lung transplant: high-frequency chest wall oscillation vs chest physiotherapy. Am J Crit Care. 2013 Mar;22(2):115-24. doi: 10.4037/ajcc2013869.'}, {'pmid': '9742334', 'type': 'BACKGROUND', 'citation': 'Massard G, Wihlm JM. Postoperative atelectasis. Chest Surg Clin N Am. 1998 Aug;8(3):503-28, viii.'}, {'pmid': '19099160', 'type': 'BACKGROUND', 'citation': 'Manzano RM, Carvalho CR, Saraiva-Romanholo BM, Vieira JE. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial. Sao Paulo Med J. 2008 Sep;126(5):269-73. doi: 10.1590/s1516-31802008000500005.'}, {'pmid': '12122521', 'type': 'RESULT', 'citation': 'Ntoumenopoulos G, Presneill JJ, McElholum M, Cade JF. Chest physiotherapy for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2002 Jul;28(7):850-6. doi: 10.1007/s00134-002-1342-2. Epub 2002 May 24.'}, {'pmid': '8650276', 'type': 'RESULT', 'citation': 'Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. doi: 10.1093/ptj/76.6.609.'}, {'pmid': '10893365', 'type': 'RESULT', 'citation': 'Oermann CM, Swank PR, Sockrider MM. Validation of an instrument measuring patient satisfaction with chest physiotherapy techniques in cystic fibrosis. Chest. 2000 Jul;118(1):92-7. doi: 10.1378/chest.118.1.92.'}, {'pmid': '15635998', 'type': 'RESULT', 'citation': 'Warwick WJ, Wielinski CL, Hansen LG. Comparison of expectorated sputum after manual chest physical therapy and high-frequency chest compression. Biomed Instrum Technol. 2004 Nov-Dec;38(6):470-5. doi: 10.2345/0899-8205(2004)38[470:COESAM]2.0.CO;2.'}, {'pmid': '8165037', 'type': 'RESULT', 'citation': 'Hansen LG, Warwick WJ, Hansen KL. Mucus transport mechanisms in relation to the effect of high frequency chest compression (HFCC) on mucus clearance. Pediatr Pulmonol. 1994 Feb;17(2):113-8. doi: 10.1002/ppul.1950170207.'}, {'pmid': '3988672', 'type': 'RESULT', 'citation': "Gross D, Zidulka A, O'Brien C, Wight D, Fraser R, Rosenthal L, King M. Peripheral mucociliary clearance with high-frequency chest wall compression. J Appl Physiol (1985). 1985 Apr;58(4):1157-63. doi: 10.1152/jappl.1985.58.4.1157."}, {'pmid': '9702607', 'type': 'RESULT', 'citation': 'Langenderfer B. Alternatives to percussion and postural drainage. A review of mucus clearance therapies: percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-frequency chest compression with the ThAIRapy Vest. J Cardiopulm Rehabil. 1998 Jul-Aug;18(4):283-9. doi: 10.1097/00008483-199807000-00005.'}, {'pmid': '19541567', 'type': 'RESULT', 'citation': 'Chen YC, Wu LF, Mu PF, Lin LH, Chou SS, Shie HG. Using chest vibration nursing intervention to improve expectoration of airway secretions and prevent lung collapse in ventilated ICU patients: a randomized controlled trial. J Chin Med Assoc. 2009 Jun;72(6):316-22. doi: 10.1016/S1726-4901(09)70378-8.'}]}, 'descriptionModule': {'briefSummary': "Effects of the high frequent chest wall oscillation technique applied on the patients who were intubated in intensive care unit were investigated.\n\nA total of 30 patients who were intubated and under the mechanical ventilator supplied, were included in the study. While the control group (n=15) received routine pulmonary rehabilitation technique, the study group (n=15) was administered high frequency chest wall oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal aspirate culture was studied at initial and 72nd. In addition, patient outcomes were evaluated at the end of the first week."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged over 18 years\n* Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital\n\nExclusion Criteria:\n\n* Patients with rib fracture\n* acute hemorrhage\n* unstable intracranial pressure\n* existence of chest drainage tube and those have history of spinal surgery,\n* skin infection in the back and chest area and subcutaneous emphysema'}, 'identificationModule': {'nctId': 'NCT02645695', 'briefTitle': 'What is the Effective Pulmonary Physiotherapy Method in Critically Care Patients?', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'Can High Frequency Chest Wall Oscillation Accelerate the Discharged of Intubated Intensive Care Patients?', 'orgStudyIdInfo': {'id': 'erzincan university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'routine pulmonary rehabilitation', 'description': 'routine pulmonary rehabilitation consisted of position giving technique', 'interventionNames': ['Device: routine pulmonary rehabilitation', 'Device: chest wall vibration technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chest wall vibration technique', 'description': 'chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours.', 'interventionNames': ['Device: routine pulmonary rehabilitation', 'Device: chest wall vibration technique']}], 'interventions': [{'name': 'routine pulmonary rehabilitation', 'type': 'DEVICE', 'description': 'received routine pulmonary rehabilitation consisted of position giving technique (left lateral, supine, right lateral), chest wall percussion, postural drainage and airway aspiration at every 3 hours.', 'armGroupLabels': ['chest wall vibration technique', 'routine pulmonary rehabilitation']}, {'name': 'chest wall vibration technique', 'type': 'DEVICE', 'description': 'administered chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours. Chest vibration method was applied with 7-10 hz frequency given by a ped wrapped around the thorax and pulmonary rehabilitation with 3 mmHg pressure four times a day with 15-minute periods (TheVest® Model 205).', 'armGroupLabels': ['chest wall vibration technique', 'routine pulmonary rehabilitation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ILKE KUPELI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'head of Anesthesiology and Reanimation', 'investigatorFullName': 'ILKE KUPELI', 'investigatorAffiliation': 'Erzincan University'}}}}