Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 5:52 AM
Study NCT ID:
NCT05345704
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2022-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}], 'ancestors': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-10', 'studyFirstSubmitDate': '2022-04-10', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial ventilation effectivity', 'timeFrame': 'During 90 seconds of life support', 'description': 'Number of ventilations that are effective out of the first 5 attempts in each group. Defined as breath that has the ability to elevate the chest'}], 'secondaryOutcomes': [{'measure': 'Delay in ventilation', 'timeFrame': 'During 90 seconds of life support', 'description': 'Time to first effective ventilation'}, {'measure': 'Initial 2 breaths effectivity', 'timeFrame': 'During 90 seconds of life support', 'description': 'Number of effective ventilation from first 2 ventilation attempts in each group'}, {'measure': 'Initial ventilation adequacy', 'timeFrame': 'During 90 seconds of life support', 'description': 'Number of ventilations with correct volumes (6-8 mL/kg) out of the first 5 attempts'}, {'measure': 'Ventilation volume during initial breaths', 'timeFrame': 'During 90 seconds of life support', 'description': 'Percentage of correct volume breaths during CPR'}, {'measure': 'Delay in CPR', 'timeFrame': 'During 90 seconds of life support', 'description': 'Time to start of chest compressions'}, {'measure': 'CPR description', 'timeFrame': 'During 90 seconds of life support', 'description': 'Number of CPR cycles (15 compressions: 2 ventilations) during 90 seconds of simulated CPR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CPR', 'resuscitation', 'pediatric', 'ventilation', 'effectiveness'], 'conditions': ['Simulated Pediatric CRP Ventilation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to gather data to support beginning the pediatric cardiopulmonary resuscitation (CPR) with 5 initial breaths. The group of health care professionals and the group lay rescuers will be asked to perform cardiopulmonary resuscitation (CRP) on 2 pediatric simulation mannequins (the 3-month-old infant, 5 kg, and the 5-year-old child, 25 kg) and the effectiveness of initial ventilation attempts will be evaluated.', 'detailedDescription': 'There is a lack of knowledge on the efficiency of ventilation during simulated and real cardiopulmonary resuscitation of children and infants. The ventilations should be an integral part of pediatric resuscitation as recommended by European Resuscitation Council (ERC) because the respiratory and other secondary causes with oxygen depletion are common causes of cardiac arrest in children. However, the effectiveness and quality of ventilation are rarely studied and ERC guidelines to start ventilation with 5 initial breaths in pediatric CPR are based on the experts´ opinion. This study evaluates ventilation efficiency during simulated pediatric cardiopulmonary resuscitation performed by 2 different groups of potential rescuers - physicians, nurses- representing the advanced life support and lay rescuers- representing the basic life support algorithm. The primary aim of this study is to evaluate the number of effective breaths (define as a visible chest rise) during 5 initial breaths attempts of simulated pediatric cardiopulmonary resuscitation. Secondary outcomes include subanalysis of the effectiveness of two initial breaths attempts, defined as a visible chest rise, time to first effective breath, breath volume delivered during 5 initial breaths, and breaths during CPR. The appropriate volume would be considered 6-10 mL/kg (i.e. 30 - 50 mL in infant and 125- 250 mL in the child). The data will be obtained before and after standardized simulation training in both groups. For lay rescuers, the dispatcher-assisted CPR will be simulated. For the health care professionals, basic equipment will be available and expected to be used (correct size mask and bag-mask ventilation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteer participants in a role lay rescuers and Health care professionals (HCPs) trained in advanced life support', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer participants - lay rescuers\n* Health care professionals performing simulated CPR\n\nExclusion Criteria:\n\n* not willing to participate'}, 'identificationModule': {'nctId': 'NCT05345704', 'acronym': 'PEDIVENT', 'briefTitle': 'Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation in Health Care Professionals and Lay Rescuers', 'orgStudyIdInfo': {'id': 'SIMU 2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lay rescuers', 'description': 'Volunteer participants in a role lay rescuers', 'interventionNames': ['Other: cardiopulmonary resuscitation (CPR)']}, {'label': 'Health care professionals (HCPs)', 'description': 'Health care professionals (HCPs) trained in advanced life support', 'interventionNames': ['Other: cardiopulmonary resuscitation (CPR)']}], 'interventions': [{'name': 'cardiopulmonary resuscitation (CPR)', 'type': 'OTHER', 'description': 'Data from observation and collected from simulation mannequin during simulated CPR of an infant and child.', 'armGroupLabels': ['Health care professionals (HCPs)', 'Lay rescuers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Brno University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Petr Stourac, prof. MD., Ph.D., MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of paediatric anaesthesia and intensive care medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Simulation Centre of the Faculty of Medicine of Masaryk University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}