Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT04548934
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2020-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067393', 'term': 'Personal Protective Equipment'}], 'ancestors': [{'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depth of chest compression', 'timeFrame': '20 minutes of CPR', 'description': 'Difference in chest compression depth during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).'}], 'secondaryOutcomes': [{'measure': 'Chest compression rate', 'timeFrame': '20 minutes of CPR', 'description': 'Difference in chest compression rate during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).'}, {'measure': 'Relaxation', 'timeFrame': '20 minutes of CPR', 'description': 'Difference in the percentage of compressions with incomplete release during a simulated cardio-pulmonary resuscitation (CPR) on manikins when performed with and without wearing personal protective equipment (PPE).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Resuscitation', 'Personal Protective Equipment']}, 'descriptionModule': {'briefSummary': 'Background The significant risk of transmission of SARS-CoV-2 to healthcare staff mandated changes to Basic and Advanced Life Support (BLS and ALS) guidelines. As advised by the European Resuscitation Council (ERC), healthcare staff should put on airborne-precaution personal protective equipment (PPE) before starting chest compressions and/or airway interventions, as a minimum an FFP3 mask (FFP2 or N95 if FFP3 not available), eye and face protection and long-sleeved gown. However, wearing FFP3 masks has been shown to highly impair cardiopulmonary exercise capacity and the effect of wearing PPE on the quality of cardiopulmonary resuscitation is not known. The aim of this project is therefore to to investigate whether wearing PPE has an effect on the quality of chest compressions.\n\nMethods The study forsees a simulated CPR scenario on manikins. Study participants are lay rescuers and members of the rescue organization Croce Bianca. Each participant will perform 5 sequences consisting of 2 min of chest compressions altered by 2 min of no chest compressions (break), as recommended by the current ERC guidelines. The participants will perform the described CPR sequence two times in a cross-over design with randomized order, once while wearing PPE and once without wearing PPE. Between the two CPR sequences (i.e. with and without PPE) a break of 60 min for recovery will be given. During both CPR sequences, the quality of chest compressions will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Member of the rescue organization "Croce Bianca"\n* Aged 18-60\n* Certified in basic life support (BLS)\n* No current COVID-19 symptoms, not being tested positive for COVID-19, no COVID-19 symptoms in the 4 weeks before the tests, no quarantine or unprotected contacts with COVID positive patients in the last 4 weeks, body temperature ≤ 37.5°on test days.\n* Obtained informed consent.\n\nExclusion Criteria:\n\n* Age \\<16 or \\>60 years,\n* No informed consent\n* Current COVID-19 symptoms, being tested positive for COVID 19 or symptoms in the 4 weeks before the tests, quarantine or unprotected contacts with COVID-19 positive patients in the last 4 weeks, body temperature ≥ 37.5°on test days.'}, 'identificationModule': {'nctId': 'NCT04548934', 'briefTitle': 'Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mountain Emergency Medicine'}, 'officialTitle': 'Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic', 'orgStudyIdInfo': {'id': 'CPR PPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No PPE', 'description': 'Cardiopulmonary resuscitation without wearing personal protective equipment (PPE)', 'interventionNames': ['Device: No Personal protective equipment (PPE)']}, {'type': 'EXPERIMENTAL', 'label': 'PPE', 'description': 'Cardiopulmonary resuscitation while wearing personal protective equipment (PPE)', 'interventionNames': ['Device: Personal protective equipment (PPE)']}], 'interventions': [{'name': 'Personal protective equipment (PPE)', 'type': 'DEVICE', 'description': 'Wearing of PPE (FFP3 mask, gloves, eye protection, long-sleeved gown)', 'armGroupLabels': ['PPE']}, {'name': 'No Personal protective equipment (PPE)', 'type': 'DEVICE', 'description': 'Standard CPR without wearing PPE', 'armGroupLabels': ['No PPE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Bolzano', 'country': 'Italy', 'facility': 'Headquarter of "Croce Bianca" EMS organization', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}], 'overallOfficials': [{'name': 'Simon Rauch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurac research, Institute of mountain emergency medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mountain Emergency Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}