RecruitingNot Applicable

Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

Norway11 participantsStarted 2025-01-30

Plain-language 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.

Who can participate

Age range18 Years – 110 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Healthy volunteers
✓. Subject must be 18 years or older
✓. Subject must be able to give written informed consent

Exclusion criteria

✕. 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

What they're measuring

Partial pressure (level) of carbon dioxide at the nasal mucosa

Timeframe: 14 hours

Trial details

NCT IDNCT06367686

SponsorThe Hospital of Vestfold

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-30

Contact for this trial

Anne-Marie Gabrielsen, MD, PhD

92485580 anne-marie.gabrielsen@siv.no

View on ClinicalTrials.gov More Hypercapnic Respiratory Failure trials