Clinical trial NCT06367686: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
Official title: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor; The DISCO-study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercapnic Respiratory Failure
Pulmonary Disease, Chronic Obstructive
Neuromuscular Diseases
Obesity Hypoventilation Syndrome (OHS)
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: Sensocure AS
First posted: 2024-04-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nine patients will be selected consequtive from the hypoventilation assessment planning program at the site. Additionally, two healthy individuals, who have no heart-, lung-, or circulatory diseases, no bleeding disorder, no sleep disorders, and no ties whatsoever to the sponsor (Sensocure AS), will be included as volunteers. Otherwise completely freely chosen by the investigators except they must not have any kind of (direct or indirect) acquaintanceship to the investigators. Eligible subjects will be invited to participate in this clinical investigation. All the subjects will be included at least one day before study procedure starts.

Brief 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.

Detailed description: he study is an open, prospective, single center clinical observational pilot investigation including 9 patients and 2 healthy volunteers. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa, with the transcutaneous carbon dioxide values measured at the forehead by a transcutaneous carbon dioxide-monitor, the arterial carbon dioxide measurements performed by blood gas analyses, and carbon dioxide measurements registered with the IscAlert sensor implanted in the muscle of the forearm. 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. The study will include patients with a tendency to hypoventilation, thereby giving rise to a carbon dioxide retention; 3 patients with chronic obstructive pulmonary disease with suspected hypercapnic respiratory failure who are evaluated for non-invasive mask-treatment and long-term oxygen treatment supply if needed. 3 patients with neuromuscular disorders and 3 patients with obesity hypoventilation syndrome who are evaluated for non-invasive mask treatment. The measurements will last for about 8 to 14 hours at night while the patients are sleeping. In addition, the study will also include 2 healthy volunteers as a control group. They will have the equipment mounted on them for about 8 hours during the day in connection with normal office work. Follow up by telephone 7 days +/-2 days after the measurements are finished. The inclusion period is expected to be about 9 months.

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

Primary outcomes:
measure: Partial pressure (level) of carbon dioxide at the nasal mucosa
timeFrame: 14 hours
Secondary outcomes:
measure: Bleeding
timeFrame: 7 days
measure: Infection
timeFrame: 7 days
measure: Sinusitis
timeFrame: 7 days
measure: Ulceration
timeFrame: 7 days
measure: Pain at sensor insertion site
timeFrame: 7 days
Other outcomes:
measure: Muscular temperature level
timeFrame: 14 hours
measure: Nasal temperature level
timeFrame: 14 hours
measure: Temporal temperature level
timeFrame: 14 hours
measure: IscAlert functionality
timeFrame: 14 hours
measure: Number of pack-years
timeFrame: 7 days
measure: Length of sensor implantation time
timeFrame: 7 days
measure: Peripheral oxygen saturation
timeFrame: 14 hours
measure: Arterial partial pressure (level) of carbon dioxide
timeFrame: 14 hours
measure: Arterial partial pressure (level) of oxygen
timeFrame: 14 hours
measure: Intramuscular partial pressure (level) of carbon dioxide
timeFrame: 14 hours
measure: Transcutaneous partial pressure (level) of carbon dioxide
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 1a - discomfort
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 1b - discomfort
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 2a - runny nose
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 2b - runny nose
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 3a - sneezing
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 3b - sneezing
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 3b - Ulceration
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 3a - Ulceration
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 4a - tenderness
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 4b - tenderness
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 5b - bleeding
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 5a - bleeding
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 6a - reduced sense of smell
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 6b - reduced sense of smell
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 7b - reduced sense of taste
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 7a - reduced sense of taste
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 8a - difficulty sleeping
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 8b - easy to wake up while sleeping
timeFrame: 7 days
measure: Patient-Reported Outcome Measures 9 - problems with eating and drinking
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 10 - difficult breathing
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses
timeFrame: 14 hours
measure: Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses
timeFrame: 7 days
Locations:
city: Tønsberg
country: Norway
facility: Vestfold Hopsital Trust
Study officials:
affiliation: The Hospital of Vestfold
name: Anne-Marie Gabrielsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: