nctId: NCT06367686 id: REK KULMU B 714179 briefTitle: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor acronym: DISCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-16 name: The Hospital of Vestfold class: OTHER name: Sensocure AS 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. conditions: Hypercapnic Respiratory Failure conditions: Pulmonary Disease, Chronic Obstructive conditions: Neuromuscular Diseases conditions: Obesity Hypoventilation Syndrome (OHS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 11 type: ESTIMATED name: IscAlert sensor measure: Partial pressure (level) of carbon dioxide at the nasal mucosa measure: Bleeding measure: Infection measure: Sinusitis measure: Ulceration measure: Pain at sensor insertion site measure: Muscular temperature level measure: Nasal temperature level measure: Temporal temperature level measure: IscAlert functionality measure: Number of pack-years measure: Length of sensor implantation time measure: Peripheral oxygen saturation measure: Arterial partial pressure (level) of carbon dioxide measure: Arterial partial pressure (level) of oxygen measure: Intramuscular partial pressure (level) of carbon dioxide measure: Transcutaneous partial pressure (level) of carbon dioxide measure: Patient-Reported Outcome Measures 1a - discomfort measure: Patient-Reported Outcome Measures 1b - discomfort measure: Patient-Reported Outcome Measures 2a - runny nose measure: Patient-Reported Outcome Measures 2b - runny nose measure: Patient-Reported Outcome Measures 3a - sneezing measure: Patient-Reported Outcome Measures 3b - sneezing measure: Patient-Reported Outcome Measures 3b - Ulceration measure: Patient-Reported Outcome Measures 3a - Ulceration measure: Patient-Reported Outcome Measures 4a - tenderness measure: Patient-Reported Outcome Measures 4b - tenderness measure: Patient-Reported Outcome Measures 5b - bleeding measure: Patient-Reported Outcome Measures 5a - bleeding measure: Patient-Reported Outcome Measures 6a - reduced sense of smell measure: Patient-Reported Outcome Measures 6b - reduced sense of smell measure: Patient-Reported Outcome Measures 7b - reduced sense of taste measure: Patient-Reported Outcome Measures 7a - reduced sense of taste measure: Patient-Reported Outcome Measures 8a - difficulty sleeping measure: Patient-Reported Outcome Measures 8b - easy to wake up while sleeping measure: Patient-Reported Outcome Measures 9 - problems with eating and drinking measure: Patient-Reported Outcome Measures 10 - difficult breathing measure: Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses measure: Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vestfold Hopsital Trust city: Tønsberg zip: 3103 country: Norway name: Anne-Marie Gabrielsen, MD, PhD role: CONTACT phone: 92485580 phoneExt: +47 email: anne-marie.gabrielsen@siv.no name: Morten Waldvogel-Rønning, MD role: CONTACT phone: 95203195 phoneExt: +47 email: morten.waldvogel-ronning@siv.no name: Morten Waldvogel-Rønning, MD role: SUB_INVESTIGATOR name: Caroline Sahlstrøm, MD role: SUB_INVESTIGATOR lat: 59.26754 lon: 10.40762 hasResults: False