Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT04201860
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2019-12-14', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline arterial blood gases analysis at 2 hours', 'timeFrame': '10 minutes before going in to the cave and two hours after the volunteers come out from the cave', 'description': 'Under aseptic conditions, a puncture of radial artery was performed: one mL was tested for the blood gases analysis, by using i-STAT analyser.'}, {'measure': 'Change from baseline haemostasis analysis at 2 hours', 'timeFrame': '10 minutes before going in to the cave and two hours after the volunteers come out from the cave', 'description': 'Under aseptic conditions, a venipuncture was performed: three mL of blood sample were used for the haemostasis measure, by using Rotational Thromboelastometry'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline heart rate at 2 hours', 'timeFrame': '10 minutes before going in to the cave and two hours after the volunteers come out from the cave', 'description': 'Haert rate was recorded by using a multiparametric monitor'}, {'measure': 'Change from baseline arterial blood pressure at 2 hours', 'timeFrame': '10 minutes before going in to the cave and two hours after the volunteers come out from the cave', 'description': 'Arterial blood pressure was recorded by using a multiparametric monitor'}, {'measure': 'Change from baseline pulse oxymetry at 2 hours', 'timeFrame': '10 minutes before going in to the cave and two hours after the volunteers come out from the cave', 'description': 'Pulse oxymetry was recorded by using a multiparametric monitor'}, {'measure': 'Change from baseline epitympanic temperature at 2 hours', 'timeFrame': '10 minutes before going in to the cave and two hours after the volunteers come out from the cave', 'description': 'Epitympanic temperature was measured by using epitympanic probe'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arterial blood gas', 'Coagulation', 'Nitrogen compounds'], 'conditions': ['Disorder of Blood Gas', 'Bleeding Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.', 'detailedDescription': 'This was a field report of clinical data collected during an accidental uncontrolled detonation of micro-charges, while the cave unblocking procedure was performed by volunteers of blaster group and non blasters group of the Italian National Mountain and Cave Rescue, in a cave in Trieste (Italy; altitude entrance: 348 meters above sea level; total length: 413,5 meters; total depth of 307 meters).\n\nBefore going into the cave (Time 0), the following clinical data were collected: age, sex, body mass index; smoke (yes/no), heart rate, arterial blood pressure (mean arterial pressure), oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures.\n\nAfter the accidental uncontrolled detonation of micro-charges, (Time 1) heart rate, arterial blood pressure, oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures were recorded in each volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers of Blasters and No Blasters Group of the Italian National Mountain and Cave Rescue', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers of Italian National Mountain and Cave Rescue\n\nExclusion Criteria:\n\n* gas exchange disorders\n* quantitative abnormalities of coagulation assessment\n* qualitative abnormalities of coagulation assessment'}, 'identificationModule': {'nctId': 'NCT04201860', 'briefTitle': 'Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds', 'organization': {'class': 'OTHER', 'fullName': "San Salvatore Hospital of L'Aquila"}, 'officialTitle': 'Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds of Blasting Gelatin: a Field Report During a Cave Accident', 'orgStudyIdInfo': {'id': '20/2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blasters group', 'description': 'The volunteers of the blasters group of Italian Mountain and Cave Rescue handled explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation.', 'interventionNames': ['Diagnostic Test: Arterial blood gas analyses and haemostasis measures']}, {'label': 'Not blasters group', 'description': 'The volunteers of the blasters group of Italian Mountain and Cave Rescue did not handle explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation.', 'interventionNames': ['Diagnostic Test: Arterial blood gas analyses and haemostasis measures']}], 'interventions': [{'name': 'Arterial blood gas analyses and haemostasis measures', 'type': 'DIAGNOSTIC_TEST', 'description': 'Under aseptic conditions, a puncture of radial artery was performed: three mL of the arterial blood sample were used for the haemostasis measure, while one mL was tested for the blood gases analysis.', 'armGroupLabels': ['Blasters group', 'Not blasters group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67051', 'city': 'Avezzano', 'country': 'Italy', 'facility': 'Barbara Pizzi', 'geoPoint': {'lat': 42.02896, 'lon': 13.42641}}], 'overallOfficials': [{'name': 'Emiliano Petrucci, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'San Salvatore Academic Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emiliano Petrucci', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emiliano Petrucci', 'investigatorAffiliation': "San Salvatore Hospital of L'Aquila"}}}}