Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-26 @ 12:01 AM
Study NCT ID:
NCT03031860
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2017-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semi-quantitative Cough Strength Score (SCSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-04', 'studyFirstSubmitDate': '2017-01-21', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Extubation outcome (success or failure), is the patient reintubate again or not and it's correlation with the level of Cough Strength Score", 'timeFrame': 'within 6 hours postextubation', 'description': 'The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '22663965', 'type': 'BACKGROUND', 'citation': 'White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850.'}]}, 'descriptionModule': {'briefSummary': 'Cough strength score will give true prediction of Extubation outcome', 'detailedDescription': 'Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation. If they had completed an Spontaneous Breathing Trial (SBT) before extubation. To measure Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30° to 45°, measure SCSS, first. The investigator enhance the patient to cough with as much effort as, when the investigator disconnect the ventilator. The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The sample of this study include 80 head trauma patients from both sex of critically ill mechanically ventilated patient admitted to trauma Intensive Care Unit (ICU).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study included 80 adult male and female patients' their ages between 18-65 years admitted to trauma ICU with head trauma, on mechanical ventilation more than 24 hours and was ready to be weaned off from mechanical ventilation after successful spontaneous breathing trial and Glasgow Coma Scale (GCS) score \\> 8 before extubation\n\nExclusion Criteria:\n\n• Patients who had undergone tracheostomy before extubation, GCS ≤ 8, chest trauma (ribs fracture and lung contusion) and patients with chronic chest disease (Chronic obstructive pulmonary disease, tuberculosis and cancer lung) were excluded from the study."}, 'identificationModule': {'nctId': 'NCT03031860', 'briefTitle': 'Semi-quantitative Cough Strength Score (SCSS)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Semi-quantitative Cough Strength Score as a Strong Predictor for Extubation Outcome in Head Trauma Patients: a Prospective Descriptive Study', 'orgStudyIdInfo': {'id': 'IRB0000871237'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Semiquantitative Cough Strength Score', 'type': 'OTHER', 'otherNames': ['(SCSS)'], 'description': 'Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university faculty of medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Eman M Aziz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assiut university faculty of nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of anesthesia and ICU', 'investigatorFullName': 'Abdelrady S Ibrahim, MD', 'investigatorAffiliation': 'Assiut University'}}}}