Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04980820
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2021-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '1. arm: starts with no mask - FFP2 mask - FFP3 mask\n2. arm: starts with no mask - FFP3 mask - FFP2 mask'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-16', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of PcCO2', 'timeFrame': '1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)', 'description': 'Change of capillary carbon dioxide partial pressure (PcCO2)'}], 'secondaryOutcomes': [{'measure': 'Change of PcO2', 'timeFrame': '1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)', 'description': 'Change of capillary oxygen partial pressure (PcO2)'}, {'measure': 'Respiratory rate', 'timeFrame': '1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)', 'description': 'Number of breaths per minute'}, {'measure': 'Exertion score', 'timeFrame': '1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)', 'description': 'Participant subjective score: "How difficult is it for you to breathe at the moment?"; scale from 1-5, 1= easy, 2= rather easy, 3= moderate, 4= rather hard, 5= hard'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercapnia']}, 'referencesModule': {'references': [{'pmid': '31971553', 'type': 'BACKGROUND', 'citation': 'Paules CI, Marston HD, Fauci AS. Coronavirus Infections-More Than Just the Common Cold. JAMA. 2020 Feb 25;323(8):707-708. doi: 10.1001/jama.2020.0757. No abstract available.'}, {'pmid': '16922771', 'type': 'BACKGROUND', 'citation': 'Fletcher SJ, Clark M, Stanley PJ. Carbon dioxide re-breathing with close fitting face respirator masks. Anaesthesia. 2006 Sep;61(9):910. doi: 10.1111/j.1365-2044.2006.04767.x. No abstract available.'}, {'pmid': '32473501', 'type': 'BACKGROUND', 'citation': 'Ozdemir L, Azizoglu M, Yapici D. Respirators used by healthcare workers due to the COVID-19 outbreak increase end-tidal carbon dioxide and fractional inspired carbon dioxide pressure. J Clin Anesth. 2020 Nov;66:109901. doi: 10.1016/j.jclinane.2020.109901. Epub 2020 May 22.'}, {'pmid': '22944510', 'type': 'BACKGROUND', 'citation': 'Kim JH, Benson SM, Roberge RJ. Pulmonary and heart rate responses to wearing N95 filtering facepiece respirators. Am J Infect Control. 2013 Jan;41(1):24-7. doi: 10.1016/j.ajic.2012.02.037. Epub 2012 Sep 1.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/publications/i/item/rational-use-of-personal-protective-equipment-for-coronavirus-disease-(covid-19)-and-considerations-during-severe-shortages', 'label': 'Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether there are any changes in the carbon dioxide partial pressure in medical staff while wearing a filtering face piece (FFP) 2 or FFP3 mask.\n\nFurthermore, changes in the capillary oxygen partial pressure, the subjective respiratory effort and the breathing rate are measured.', 'detailedDescription': 'In the fight against the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), the personal protective equipment (PPE) of medical staff plays a special role. Since the pathogen can be transmitted via droplets, particle-filtering half masks (filtering face piece - FFP) are a substantial part of the PPE. The current data indicate that there may be an increase in the carbon dioxide partial pressure (PcCO2) in the blood when wearing an FFP2 / 3 mask during routine medical activity.\n\nThe aim of this prospective cross-over study is to compare the PcCO2 measured by capillary blood sampling from medical staff while wearing an FFP2 or FFP3 mask. The PcCO2 determined without a mask serves as a reference value. While no mask is worn, the PcCO2, the subjective respiratory effort, the breathing rate and the capillary oxygen partial pressure (PcO2) is measured. The study participants then wear an FFP2 or FFP3 mask for one hour, and the same parameters are collected. Subsequently, the participant switches to an FFP3 or FFP2 mask, and the last measurement is conducted after one hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medical staff working at the Vienna General Hospital\n* oral and written consent to take part voluntarily in this trial\n\nExclusion Criteria:\n\n* hypersensitivity / allergy against Nonylvanillamid, Nikotinsäure-beta-butoxyethylester or other component of "Finalgon Salbe"\n* not Coronavirus disease-19 vaccinated\n* pregnancy\n* breastfeeding'}, 'identificationModule': {'nctId': 'NCT04980820', 'briefTitle': 'Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Changes in Capillary pCO2 While Wearing FFP2 and FFP3 Masks Masks by Medical Staff - a Prospective Cross-over Study', 'orgStudyIdInfo': {'id': '1144/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FFP2', 'description': 'This arm starts with a FFP2 mask and switches to a FFP3 mask.', 'interventionNames': ['Other: No mask', 'Device: Filtering face mask 2 (FFP2)', 'Device: Filtering face mask 3 (FFP3)']}, {'type': 'EXPERIMENTAL', 'label': 'FFP3', 'description': 'This arm starts with a FFP3 mask and switches to a FFP2 mask.', 'interventionNames': ['Other: No mask', 'Device: Filtering face mask 2 (FFP2)', 'Device: Filtering face mask 3 (FFP3)']}], 'interventions': [{'name': 'No mask', 'type': 'OTHER', 'description': 'The participant is asked to wear no mask for 10 minutes.', 'armGroupLabels': ['FFP2', 'FFP3']}, {'name': 'Filtering face mask 2 (FFP2)', 'type': 'DEVICE', 'description': 'The participant is asked to wear a FFP2 mask for 1 hour during work.', 'armGroupLabels': ['FFP2', 'FFP3']}, {'name': 'Filtering face mask 3 (FFP3)', 'type': 'DEVICE', 'description': 'The participant is asked to wear a FFP3 mask for 1 hour during work.', 'armGroupLabels': ['FFP2', 'FFP3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Georg Röder, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. PD Dr. David Baron, EDIC', 'investigatorFullName': 'David M Baron, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}