Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor; The DISCO-study
The Hospital of Vestfold
11 participants
Jan 30, 2025
OBSERVATIONAL
Summary
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.
Eligibility
Inclusion Criteria10
- EITHER
- Patient are at risk of hypoventilation and thus carbon dioxide retention.
- Either
- Under evaluation for treatment with non-invasive ventilation and maybe Long term oxygen treatment due to chronic obstructive pulmonary disease or
- Under evaluation for non-invasive ventilation support due to Obesity hypoventilation syndrome or due to a neuromuscular disorder.
- OR
- Healthy volunteers
- ALL subjects:
- Subject must be 18 years or older
- Subject must be able to give written informed consent
Exclusion Criteria5
- Known allergy to local anesthetics.
- Participants should not have any kind of (direct or indirect) affiliation to Sensocure AS
- Healthy volunteers: No heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders
- Healthy volunteers should not have any kind of (direct or indirect) acquaintanceship to the investigators
- Active smoker/use of snuff
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Interventions
Insertion of an IscAlert sensor at the nasal mucosa
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06367686