Measuring carbon dioxide levels using a new biosensor

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

This study is testing a new sensor that measures carbon dioxide levels near the nose to see if it can reliably track levels in patients at risk of breathing problems while they sleep.

Quick facts

• Study type: Observational
• Enrollment: 11 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: The Hospital of Vestfold (Academic / other)
• Locations: 1 site (Tønsberg)
• Trial ID: NCT06367686 on ClinicalTrials.gov

What this trial studies

This observational pilot investigation aims to evaluate the feasibility of measuring carbon dioxide levels using the IscAlert sensor placed near the nasal mucosa. The study will compare these measurements with transcutaneous and arterial carbon dioxide values in patients at risk of hypoventilation, including those with chronic obstructive pulmonary disease, neuromuscular disorders, and obesity hypoventilation syndrome. The study will involve 9 patients and 2 healthy volunteers, with measurements taken overnight while participants sleep. The goal is to determine if nasal mucosa measurements can serve as a reliable surrogate for systemic carbon dioxide levels.

Who should consider this trial

Good fit: Ideal candidates include adults at risk of hypoventilation due to chronic obstructive pulmonary disease, neuromuscular disorders, or obesity hypoventilation syndrome.

Not a fit: Patients with known allergies to local anesthetics or those with heart, lung, or circulatory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive method for monitoring carbon dioxide levels in patients with respiratory issues.

How similar studies have performed: While this approach is novel, similar studies have shown promise in non-invasive monitoring of respiratory conditions.

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

Where this trial is running

Tønsberg

• Vestfold Hopsital Trust — Tønsberg, Norway (Recruiting)

Study contacts

• Principal investigator: Anne-Marie Gabrielsen, MD, PhD — The Hospital of Vestfold
• Study coordinator: Anne-Marie Gabrielsen, MD, PhD

Conditions Hypercapnic Respiratory Failure; Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome