protocolSection identificationModule nctId: NCT06367686, orgStudyIdInfo id: REK KULMU B 714179, briefTitle: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor, acronym: DISCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The Hospital of Vestfold, class: OTHER, collaborators name: Sensocure AS, descriptionModule briefSummary: The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values., conditionsModule conditions: Hypercapnic Respiratory Failure, conditions: Pulmonary Disease, Chronic Obstructive, conditions: Neuromuscular Diseases, conditions: Obesity Hypoventilation Syndrome (OHS), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 11, type: ESTIMATED, armsInterventionsModule interventions name: IscAlert sensor, outcomesModule primaryOutcomes measure: Partial pressure (level) of carbon dioxide at the nasal mucosa, secondaryOutcomes measure: Bleeding, secondaryOutcomes measure: Infection, secondaryOutcomes measure: Sinusitis, secondaryOutcomes measure: Ulceration, secondaryOutcomes measure: Pain at sensor insertion site, otherOutcomes measure: Muscular temperature level, otherOutcomes measure: Nasal temperature level, otherOutcomes measure: Temporal temperature level, otherOutcomes measure: IscAlert functionality, otherOutcomes measure: Number of pack-years, otherOutcomes measure: Length of sensor implantation time, otherOutcomes measure: Peripheral oxygen saturation, otherOutcomes measure: Arterial partial pressure (level) of carbon dioxide, otherOutcomes measure: Arterial partial pressure (level) of oxygen, otherOutcomes measure: Intramuscular partial pressure (level) of carbon dioxide, otherOutcomes measure: Transcutaneous partial pressure (level) of carbon dioxide, otherOutcomes measure: Patient-Reported Outcome Measures 1a - discomfort, otherOutcomes measure: Patient-Reported Outcome Measures 1b - discomfort, otherOutcomes measure: Patient-Reported Outcome Measures 2a - runny nose, otherOutcomes measure: Patient-Reported Outcome Measures 2b - runny nose, otherOutcomes measure: Patient-Reported Outcome Measures 3a - sneezing, otherOutcomes measure: Patient-Reported Outcome Measures 3b - sneezing, otherOutcomes measure: Patient-Reported Outcome Measures 3b - Ulceration, otherOutcomes measure: Patient-Reported Outcome Measures 3a - Ulceration, otherOutcomes measure: Patient-Reported Outcome Measures 4a - tenderness, otherOutcomes measure: Patient-Reported Outcome Measures 4b - tenderness, otherOutcomes measure: Patient-Reported Outcome Measures 5b - bleeding, otherOutcomes measure: Patient-Reported Outcome Measures 5a - bleeding, otherOutcomes measure: Patient-Reported Outcome Measures 6a - reduced sense of smell, otherOutcomes measure: Patient-Reported Outcome Measures 6b - reduced sense of smell, otherOutcomes measure: Patient-Reported Outcome Measures 7b - reduced sense of taste, otherOutcomes measure: Patient-Reported Outcome Measures 7a - reduced sense of taste, otherOutcomes measure: Patient-Reported Outcome Measures 8a - difficulty sleeping, otherOutcomes measure: Patient-Reported Outcome Measures 8b - easy to wake up while sleeping, otherOutcomes measure: Patient-Reported Outcome Measures 9 - problems with eating and drinking, otherOutcomes measure: Patient-Reported Outcome Measures 10 - difficult breathing, otherOutcomes measure: Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses, otherOutcomes measure: Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vestfold Hopsital Trust, city: Tønsberg, zip: 3103, country: Norway, contacts name: Anne-Marie Gabrielsen, MD, PhD, role: CONTACT, phone: 92485580, phoneExt: +47, email: anne-marie.gabrielsen@siv.no, contacts name: Morten Waldvogel-Rønning, MD, role: CONTACT, phone: 95203195, phoneExt: +47, email: morten.waldvogel-ronning@siv.no, contacts name: Morten Waldvogel-Rønning, MD, role: SUB_INVESTIGATOR, contacts name: Caroline Sahlstrøm, MD, role: SUB_INVESTIGATOR, geoPoint lat: 59.26754, lon: 10.40762, hasResults: False