Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT00632320
Status:
COMPLETED
Last Update Posted:
2008-03-10
First Post:
2008-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-07', 'studyFirstSubmitDate': '2008-03-02', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The patients connecting or disconnecting to the ventilators affected the RSBI values but not their predictive accuracies.', 'timeFrame': 'Before the patient processing weaning trials'}], 'secondaryOutcomes': [{'measure': 'Changes in FiO2 and CPAP settings have no effect on RSBI values but ventilator methods with FiO2 21% have higher incidence of adverse reactions.', 'timeFrame': 'Before the patient processing weaning trials'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ventilator, mechanical', 'Ventilator weaning', 'Rapid shallow breathing index', 'Continuous positive airway pressure', 'Receiver operating characteristic curve', 'COPD'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'To compare the rapid shallow breathing index (RSBI) values, the incidence of adverse reactions, and the predictive accuracy measured under 5 different ventilator strategies in the same patient group.', 'detailedDescription': '98 ready for weaning patients were included and divided into success (n=71) and failure (n=27) groups based upon their weaning outcome. Before weaning, the RSBI values were determined under the patients disconnecting from the ventilator (RA-no ventilator) and still connecting to the ventilator with 4 different settings (fraction of inspired oxygen (FiO2) 21 or 40% combined with continuous positive airway pressure (CPAP) 0 or 5 cm H2O). The patients were extubated after completing the weaning trials. Successful weaning was defined as patients free from the ventilator for over 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'respiratory therapy intensive Care unit in a medical center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intubated medical patients with mechanically ventilated more than 48 hours\n* clinically ready for weaning\n* Glasgow coma scales were at least 8\n* their ventilator settings were: assist-controlled, pressure support (PS)or synchronized intermittent mandatory ventilation plus PS mode, FiO2 40% or less, positive end-expiratory pressure 5 cm H2O or less, and sensitivity setting on 1 L/min. Their arterial blood gases results were acceptable\n\nExclusion Criteria:\n\n* having ongoing lung or neuromuscular disease and signs of increased intracranial pressure'}, 'identificationModule': {'nctId': 'NCT00632320', 'briefTitle': 'Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure and Oxygen Concentration on Measurement of Rapid Shallow Breathing Index', 'orgStudyIdInfo': {'id': 'VGHIRB No.:93-09-02A'}, 'secondaryIdInfos': [{'id': 'Grant 94CM-TMU-13'}, {'id': 'Grant NSC94-2314-B-038-039'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'S, 1, A', 'description': 'group (success or failure), case number, measurement method'}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Respiratory Therapy Intensive Care Unit, Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Mauo-Ying Bien, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan, ROC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Mauo-Ying Bien PhD, RPT, RRT/Assistant Professor', 'oldOrganization': 'School of Respiratory Therapy, Taipei Medical University, Taipei, Taiwan'}}}}