Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-02-24 @ 3:17 PM
Study NCT ID:
NCT02278835
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D007384', 'term': 'Intermittent Positive-Pressure Breathing'}, {'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-29', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Respiratory Muscle Strength', 'timeFrame': 'Patients were followed for five days', 'description': 'Maximum inspiratory pressure (MIP)'}, {'measure': 'Respiratory Muscle Strength', 'timeFrame': 'Patients were followed for five days', 'description': 'Maximum expiratory pressure (MEP)'}], 'primaryOutcomes': [{'measure': 'incidence of atelectasis', 'timeFrame': 'Patients were followed for five days'}], 'secondaryOutcomes': [{'measure': 'pulmonary function', 'timeFrame': 'Patients were followed for five days', 'description': 'Forced vital capacity in liters and percentual (FVC; %FVC )'}, {'measure': 'pulmonary function', 'timeFrame': 'Patients were followed for five days', 'description': 'Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)'}, {'measure': 'pulmonary function', 'timeFrame': 'Patients were followed for five days', 'description': 'Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac valve'], 'conditions': ['Mitral Valve Disease']}, 'referencesModule': {'references': [{'pmid': '10669276', 'type': 'BACKGROUND', 'citation': 'Matte P, Jacquet L, Van Dyck M, Goenen M. Effects of conventional physiotherapy, continuous positive airway pressure and non-invasive ventilatory support with bilevel positive airway pressure after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2000 Jan;44(1):75-81. doi: 10.1034/j.1399-6576.2000.440114.x.'}, {'pmid': '14670881', 'type': 'RESULT', 'citation': 'Pasquina P, Tramer MR, Walder B. Prophylactic respiratory physiotherapy after cardiac surgery: systematic review. BMJ. 2003 Dec 13;327(7428):1379. doi: 10.1136/bmj.327.7428.1379.'}]}, 'descriptionModule': {'briefSummary': 'This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge.\n\nPatients were allocated in groups according their pulmonary function (FVC: forced vital capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation; respiratory frequency (f); the ability to expectorate and the functional independence.\n\nThe group I was allocated those patients which presented decrease of up to 50% of forced vital capacity (FVC) of preoperative period, SpO2\\>92%, minimal pulmonary auscultation alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance; independence to sit; respiratory. In these patients were randomized for two interventions: a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive spirometer: used Coach® three sets of 10 repetitions.\n\nPatients allocated in the group II presented FVC\\> 30% \\<49% of preoperative period, ≥ 88% SpO2 \\<92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f\\> 25 \\<31ipm; dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in the morning and another in the afternoon.\n\nAll of the patients were conducted in effort to mobilize upper and lower limbs. On the first day, the patients walked at least 50 meters, by increasing the distance to at least 150 meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.', 'detailedDescription': 'The study were conducted with individuals of both gender, aged between 18 and 60 years, candidates for mitral valve surgery, up to a maximum 2nd valve replacement. Patients unable to perform the functional tests were excluded and patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for mitral valve surgery, up to a maximum 2nd valve replacement\n\nExclusion Criteria:\n\n* Patients unable to perform the functional tests\n* Patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours'}, 'identificationModule': {'nctId': 'NCT02278835', 'briefTitle': 'The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'To Analyze the Effectiveness of Respiratory Physiotherapy Techniques in the Post Operative Mitral Valve', 'orgStudyIdInfo': {'id': 'CAPPesq 0011/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'level1', 'description': 'Patients classified in level 1 were randomized in the breathing exercises group or incentive spirometry group', 'interventionNames': ['Other: breathing exercises', 'Device: incentive spirometry']}, {'type': 'OTHER', 'label': 'level2', 'description': 'Patients classified in level 2 were randomized in the Intermittent Positive Pressure Breathing group or Continuous Positive Airway Pressure group', 'interventionNames': ['Device: Intermittent positive pressure breathing', 'Device: Continuous positive airway pressure']}], 'interventions': [{'name': 'breathing exercises', 'type': 'OTHER', 'otherNames': ['EXE'], 'description': '3 sets of 10 repetitions of deep breathing exercises', 'armGroupLabels': ['level1']}, {'name': 'incentive spirometry', 'type': 'DEVICE', 'otherNames': ['IS (Coach®)'], 'description': '3 sets of 10 repetitions of deep breathing exercises with incentive spirometry', 'armGroupLabels': ['level1']}, {'name': 'Intermittent positive pressure breathing', 'type': 'DEVICE', 'otherNames': ['IPPB (BIRD Mark 7™)'], 'description': '20 minutes breathing with intermittent positive pressure', 'armGroupLabels': ['level2']}, {'name': 'Continuous positive airway pressure', 'type': 'DEVICE', 'otherNames': ['CPAP (Sullivan®)'], 'description': '20 minutes breathing with continuous positive airway pressure', 'armGroupLabels': ['level2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Drª Maria Ignez Zanetti Feltrim', 'investigatorFullName': 'Maria Ignez Zanetti Feltrim', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}