RecruitingNCT06367686

Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor; The DISCO-study


Sponsor

The Hospital of Vestfold

Enrollment

11 participants

Start Date

Jan 30, 2025

Study Type

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

Min Age: 18 YearsMax Age: 110 Years

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

DEVICEIscAlert sensor

Insertion of an IscAlert sensor at the nasal mucosa


Locations(1)

Vestfold Hopsital Trust

Tønsberg, Norway

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NCT06367686