Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-28 @ 5:16 PM
Study NCT ID:
NCT02040168
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of the ventilation period', 'timeFrame': 'Hospitalization + 8 weeks', 'description': '30% decrease of the ventilation period'}], 'secondaryOutcomes': [{'measure': 'evaluate the impact of sedation protocol on short-term consequences of prolonged sedation', 'timeFrame': 'Hospitalization + 8 weeks', 'description': 'Hospitalization length reduction PTSD incidence reduction of 50% Weaning syndrom incidence decrease Sedation drugs total dose decrease Decrease of mechanical ventilation related infections Decrease of accidental or self extubation frequency Required amine total dose decrease Correlation between sedation level and PTSD frequency Analysis of PTSD risk factors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ventilation', 'PTSD', 'sedation'], 'conditions': ['Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': "Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation. Sedation is a generic term for all procedures, pharmacological or not, ensuring physical and psychological comfort and the safety of patient admitted in intensive care units.\n\nAn inadequate sedation, insufficient or excessive, has common side effects, as increase of the duration of mechanical ventilation and of hospital-acquired infections (in particular, ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD). All these complications increase mechanical ventilation time and ICU length of stay. Several studies in adult's population have shown that the implementation of a sedation algorithm allowed to decrease the incidence of these complications.\n\nWe hypothetized that the duration of mechanical ventilation would be reduced by a nurse-implemented sedative management protocol.", 'detailedDescription': '1. During the first period (15 months), no protocol is used. This period consists to assess current analgesia-sedation procedure used in the pediatric intensive care unit (PICU), associated with the collection of medical and socio-demographical data about mechanical ventilation duration, sedation complications, PTSD development. The severity of pathology can be evaluated using PIM2 and POPC scores. The sedation deepness will be determined using COMFORT-B scale. Eight weeks after hospitalization, families will be phoned to assess children memories, anxious troubles, and PTSD symptoms for the patients of more than 18 months old.\n2. During the transition period (6 months), nurses and physicians develop the protocol and undergo training in its use.\n\nDuring the third period, a nurse-implemented sedation is used. The collected data are the same that the collected data during the first period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The old children from 28 days to 18 years admitted in pediatric intensive care unit of Nantes University Hospital requiring mechanical ventilation for at least 24 hours can be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 28 days to 18 years\n* Admitted in pediatric intensive care unit\n* Necessity of mechanical ventilation \\> 24 hours.\n\nExclusion Criteria:\n\n* Sedation started in another intensive care unit \\> 24 hours'}, 'identificationModule': {'nctId': 'NCT02040168', 'acronym': 'PEDIASED', 'briefTitle': 'Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation of the Interest of a Nurse-implemented Sedation Protocol for the Reduction of the Duration of Mechanical Ventilation Complication Associated With Extended Sedation in Pediatric Intensive Care Unit.', 'orgStudyIdInfo': {'id': 'PROG/10/53'}}, 'armsInterventionsModule': {'armGroups': [{'label': '28 days - 18 yo', 'description': 'Children requiring mechanical ventilation for at least 24h from 28 days to 18 yo'}, {'label': '18 months - 18 yo', 'description': 'Post traumatic stress disorder evaluation in children requiring mechanical ventilation for at least 24h from 18 month to 18 Years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Liet Jean Michel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}