Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

NCT06367686 | Recruiting

• 1 other identifier: REK KULMU B 714179
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercapnic Respiratory Failure; Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome (OHS)

Outcome Measures

Primary Outcomes (1)

• Partial pressure (level) of carbon dioxide at the nasal mucosa

  Nasal mucosa's partial pressure of carbon dioxide (kPa) during insertion period

  14 hours

Secondary Outcomes (5)

• Bleeding

  7 days

• Infection

  7 days

• Sinusitis

  7 days

• Ulceration

  7 days

• Pain at sensor insertion site

  7 days

Other Outcomes (33)

• Muscular temperature level

  14 hours

• Nasal temperature level

  14 hours

• Temporal temperature level

  14 hours

Study Arms (4)

Chronic obstructive pulmonary disease

3 Chronic obstructive pulmonary disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night

Device: IscAlert sensor

Neuromuscular disease

3 Neuromuscular disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night

Device: IscAlert sensor

Obesity hypoventilation syndrome

3 Obesity hypoventilation syndrome patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night

Device: IscAlert sensor

Healthy volunteers

2 healthy volunteers monitored with IscAlert sensor at nasal mucosa for approximately 8 hours during daytime

Device: IscAlert sensor

Interventions

IscAlert sensor DEVICE

Insertion of an IscAlert sensor at the nasal mucosa

Chronic obstructive pulmonary disease; Healthy volunteers; Neuromuscular disease; Obesity hypoventilation syndrome

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Healthy volunteers
• ALL subjects:
• Subject must be 18 years or older
• Subject must be able to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital of Vestfold: lead
• Sensocure AS: collaborator

Study Sites (1)

Vestfold Hopsital Trust

Tønsberg, 3103, Norway

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Hypoventilation; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Anne-Marie Gabrielsen, MD, PhD

  The Hospital of Vestfold

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Marie Gabrielsen, MD, PhD

CONTACT

92485580; anne-marie.gabrielsen@siv.no

Espen Lindholm, MD, PhD

CONTACT

92213346; espen.lindholm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 16, 2024
• Study Start: January 30, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 19, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)