Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-11 @ 1:40 PM
Study NCT ID:
NCT03790150
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Approach to Standardize and Improve Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic 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', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27966}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2018-12-28', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator-associated events', 'timeFrame': '18 months', 'description': 'Ventilator-associated events rate per 1000 ventilator days in 18 months'}], 'secondaryOutcomes': [{'measure': 'Sub-glottic endotracheal tube compliance rate', 'timeFrame': '18 months', 'description': 'The percentage of ventilator days with sub-glottic endotracheal tube use'}, {'measure': 'Head of bed elevation compliance rate', 'timeFrame': '18 months', 'description': 'The percentage of ventilator days with head of bed elevation ≥30 degrees'}, {'measure': 'Spontaneous awakening trial (SAT) compliance rate', 'timeFrame': '18 months', 'description': 'The percentage of ventilator days with spontaneous awakening trial (SAT)'}, {'measure': 'Percentage of ventilated patient days without sedation', 'timeFrame': '18 months', 'description': 'The percentage of ventilated patient days without sedation use'}, {'measure': 'Spontaneous breathing trials (SBT) compliance rate', 'timeFrame': '18 months', 'description': 'The percentage of ventilator days with spontaneous breathing trial (SBT)'}, {'measure': 'Percentage of ventilated patient days without neuromuscular blockers', 'timeFrame': '18 months', 'description': 'The percentage of ventilated patient days without neuromuscular blockers'}, {'measure': 'Percentage of out of bed mobility', 'timeFrame': '18 months', 'description': 'The percentage of ventilated patient days with out of bed mobility'}, {'measure': 'Percentage of CAM-ICU negative (no delirium)', 'timeFrame': '18 months', 'description': 'The percentage of ventilator days with CAM-ICU negative (no delirium)'}, {'measure': '90-day mortality', 'timeFrame': '90 days', 'description': 'The 90-day ICU mortality rate of ventilated patients'}, {'measure': 'Mechanical ventilation duration', 'timeFrame': '90 days', 'description': 'The duration of mechanical ventilation in calendar days'}, {'measure': 'ICU length of stay', 'timeFrame': '90 days', 'description': 'The number of calendar days from ICU admission to discharge from ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventilator-associated pneumonia', 'Mechanical Ventilation', 'Ventilator-associated events', 'Intensive care unit', 'Quality improvement project'], 'conditions': ['Mechanical Ventilation Complication']}, 'referencesModule': {'references': [{'pmid': '36716310', 'type': 'DERIVED', 'citation': 'Arabi YM, Al Aseri Z, Alsaawi A, Al Khathaami AM, Al Qasim E, Alzahrani AA, Al Qarni M, Abdukahil SAI, Al-Dorzi HM, Alattasi A, Mandourah Y, Alaama TY, Alabdulaali MK, Alqahtani A, Shuaibi A, Al Qarni A, Alkatheri M, Al Hazme RH, Vishwakarma RK, Aldibasi O, Alshahrani MS, Attia A, Alharthy A, Mady A, Abdelrahman BA, Mhawish HA, Abdallah HA, Al-Hameed F, Alghamdi K, Alghamdi A, Almekhlafi GA, Qasim SAH, Al Haji HA, Al Mutairi M, Tashkandi N, Alabbasi SO, Al Shehri T, Moftah E, Kalantan B, Matroud A, Naidu B, Al Zayer S, Burrows V, Said Z, Soomro NA, Yousef MH, Fattouh AA, Tahoon MA, Muhammad M, Alruwili AM, Al Hanafi HA, Dandekar PB, Ibrahim K, AlHomsi M, Al Harbi AR, Saleem A, Masih E, Al Rashidi NM, Amanatullah AK, Al Mubarak J, Al Radwan AAA, Al Hassan A, Al Muoalad S, Alzahrani AA, Chalabi J, Qureshi A, Al Ansari M, Sallam H, Elhazmi A, Alkhaldi F, Malibary A, Ababtain A, Latif A, Berenholtz SM; Saudi Critical Care Trials Group. Impact of a national collaborative project to improve the care of mechanically ventilated patients. PLoS One. 2023 Jan 30;18(1):e0280744. doi: 10.1371/journal.pone.0280744. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This is a pre-post implementation cohort study. This is a data driven quality improvement project which aims to improve the care of mechanically ventilated patients through the implementation of a bundle of evidence based practices, with a goal of reducing ventilator associated events and mortality.', 'detailedDescription': 'NASAM is a national collaborative quality improvement project in Saudi Arabia which aims to:\n\n1. Reduce the rate of ventilator-associated events\n2. Improve the compliance with NASAM bundle elements\n3. Reduce the mortality of mechanically ventilated patients\n\nThe plan of this quality improvement project is to extend the implementation to a total of 100 ICUs in collaboration with multiple health systems across the country. A significant component of this project includes measuring the safety culture of ICUs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients admitted to intensive care units\n\nExclusion Criteria:\n\n* Age less than 14 years old'}, 'identificationModule': {'nctId': 'NCT03790150', 'acronym': 'NASAM', 'briefTitle': 'National Approach to Standardize and Improve Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'National Approach to Standardize and Improve Mechanical Ventilation Care for Critically Ill Patients in Saudi Arabia', 'orgStudyIdInfo': {'id': 'RC 17/223'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanically Ventilated Patients', 'description': 'All patients admitted to the critical care unit and require mechanical ventilation', 'interventionNames': ['Other: Evidence-based practices']}], 'interventions': [{'name': 'Evidence-based practices', 'type': 'OTHER', 'description': 'Implementation of evidence-based practices', 'armGroupLabels': ['Mechanically Ventilated Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '22490', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Abdullah International Medical Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Yaseen M Arabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdullah Medical City, Ministry of National Guard Health Affairs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Saudi Arabia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Intensive Care Unit', 'investigatorFullName': 'Dr Yaseen Arabi', 'investigatorAffiliation': 'King Abdullah International Medical Research Center'}}}}