Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

Launched by THE HOSPITAL OF VESTFOLD · Apr 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the IscAlert sensor, which measures carbon dioxide levels in the body. It’s designed to be placed near the nose to see if this method is safe and effective for tracking carbon dioxide levels, especially in patients who may have trouble breathing properly due to conditions like chronic obstructive pulmonary disease (COPD), obesity hypoventilation syndrome, or certain neuromuscular diseases. The researchers want to find out if using this sensor can provide reliable information about carbon dioxide levels in the blood, which could help in managing these conditions better.

To participate in this trial, you need to be at least 18 years old and either be at risk of retaining carbon dioxide due to breathing problems or be a healthy volunteer without any heart, lung, or sleep disorders. Participants will have the sensor placed near their nose, and the study will look at how well it works and what, if any, complications might arise from its use. This trial is currently recruiting participants, and everyone involved will have the opportunity to provide informed consent before joining. It's an important step toward improving how we monitor and treat breathing issues in patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The subject must meet all of the following inclusion criteria at the time of enrolment:
• • EITHER
• • 1. Patient are at risk of hypoventilation and thus carbon dioxide retention.
• • 2. Either
• • 1. Under evaluation for treatment with non-invasive ventilation and maybe Long term oxygen treatment due to chronic obstructive pulmonary disease or
• • 2. Under evaluation for non-invasive ventilation support due to Obesity hypoventilation syndrome or due to a neuromuscular disorder.
• • OR
• • 3. Healthy volunteers
• ALL subjects:
• • 4. Subject must be 18 years or older
• • 5. Subject must be able to give written informed consent
• Exclusion Criteria:
• • 1. Known allergy to local anesthetics.
• • 2. Participants should not have any kind of (direct or indirect) affiliation to Sensocure AS
• • 3. Healthy volunteers: No heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders
• • 4. Healthy volunteers should not have any kind of (direct or indirect) acquaintanceship to the investigators
• • 5. Active smoker/use of snuff