Actively Recruiting
Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor; The DISCO-study
Led by The Hospital of Vestfold · Updated on 2025-03-26
11
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
T
The Hospital of Vestfold
Lead Sponsor
S
Sensocure AS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an open, prospective, single-center observational pilot study to compare carbon dioxide levels measured by a novel IscAlert sensor placed near the nasal mucosa. The study aims to evaluate the feasibility of nasal mucosa application, identify potential complications, and determine if these measurements can serve as a surrogate for systemic carbon dioxide levels. Participants include patients with a tendency to hypoventilation and healthy volunteers as controls. The study involves using the IscAlert sensor inserted in the nasal mucosa to measure carbon dioxide levels, which will be compared to transcutaneous measurements at the forehead, arterial blood gas analyses, and measurements from the sensor implanted in the forearm muscle. Participants with chronic obstructive pulmonary disease, neuromuscular disorders, or obesity hypoventilation syndrome will be monitored overnight for 8 to 14 hours, while healthy volunteers will wear the device for about 8 hours during daytime office activities. Participants will undergo carbon dioxide monitoring during the specified periods, followed by telephone follow-up 7 days after measurements to check for complications such as bleeding, infection, sinusitis, ulceration, or pain at the sensor insertion site. The primary outcome is the partial pressure of carbon dioxide at the nasal mucosa measured over 14 hours. The inclusion period is expected to last about 9 months, with total participant involvement including the measurement and follow-up phases.
CONDITIONS
Brief Title
Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient at risk of hypoventilation causing carbon dioxide retention
- Under evaluation for non-invasive ventilation or long-term oxygen treatment due to chronic obstructive pulmonary disease
- Under evaluation for non-invasive ventilation due to obesity hypoventilation syndrome or neuromuscular disorder
- Healthy volunteers
- 18 years or older
- Able to give written informed consent
You will not qualify if you...
- Known allergy to local anesthetics
- Any direct or indirect affiliation to Sensocure AS
- Healthy volunteers with heart, lung, or circulatory diseases, bleeding disorders, or sleep disorders
- Healthy volunteers with any direct or indirect acquaintanceship to the investigators
- Active smoker or use of snuff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 14 hours
Participants have the IscAlert sensor inserted near the nasal mucosa and are monitored for carbon dioxide levels.
1 monitoring period during night for patients; 1 monitoring period during daytime for healthy volunteers
Duration - 7 days ± 2 days
Participants are followed up by telephone to assess any complications such as bleeding, infection, sinusitis, ulceration, or pain at the sensor insertion site.
1 telephone follow-up
Trial Site Locations
Total: 1 location
1
Vestfold Hopsital Trust
Tønsberg, Norway, 3103
Actively Recruiting
Research Team
A
Anne-Marie Gabrielsen, MD, PhD
E
Espen Lindholm, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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