Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor (DISCO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Hypercapnic Respiratory Failure; Obesity Hypoventilation Syndrome (OHS)
• Intervention / Treatment: Device: IscAlert sensor

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.

• Study Type: Observational
• Enrollment (Estimated): 11

Contacts and Locations

• Study Contact: Name: Anne-Marie Gabrielsen, MD, PhD; Phone Number: +47 92485580; Email: anne-marie.gabrielsen@siv.no
• Study Contact Backup: Name: Espen Lindholm, MD, PhD; Phone Number: +47 92213346; Email: espen.lindholm@gmail.com

Study Locations

• Norway
  • Tønsberg, Norway, 3103
    • Vestfold Hopsital Trust
    • Contact: Anne-Marie Gabrielsen, MD, PhD; Phone Number: +47 92485580; Email: anne-marie.gabrielsen@siv.no
    • Contact: Morten Waldvogel-Rønning, MD; Phone Number: +47 95203195; Email: morten.waldvogel-ronning@siv.no
    • Sub-Investigator: Morten Waldvogel-Rønning, MD
    • Sub-Investigator: Caroline Sahlstrøm, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Insertion of an IscAlert sensor at the nasal mucosa
Neuromuscular disease; 3 Neuromuscular disease patients monitored with IscAlert sensor at nasal mucosa for 8-14 hours during the night	Device: IscAlert sensor; Insertion of an IscAlert sensor at the nasal mucosa
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; Insertion of an IscAlert sensor at the nasal mucosa
Healthy volunteers; 2 healthy volunteers monitored with IscAlert sensor at nasal mucosa for approximately 8 hours during daytime	Device: IscAlert sensor; Insertion of an IscAlert sensor at the nasal mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Amount of blood from insertion site (ml)	7 days
Infection	Infection from insertion site at the discretion of the investigator (yes or no)	7 days
Sinusitis	Developement of sinusitis at the discretion of the investigator (yes or no)	7 days
Ulceration	Developement of ulceration at the nasal mucosa at the discretion of the investigator (yes or no)	7 days
Pain at sensor insertion site	Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular temperature level	Muscular temperature level (grade Celsius) during insertion period	14 hours
Nasal temperature level	Nasal temperature level (grade Celsius) during insertion period	14 hours
Temporal temperature level	Temporal temperature level (grade Celsius) during insertion period	14 hours
IscAlert functionality	Number of hours with a well-functioning sensor (giving carbon dioxide- and temperature data)	14 hours
Number of pack-years	Smoking habit; number of pack-years by participants	7 days
Length of sensor implantation time	Length of sensor implantation time during hospitalisation	7 days
Peripheral oxygen saturation	Peripheral oxygen saturation (SpO2)	14 hours
Arterial partial pressure (level) of carbon dioxide	Arterial partial pressure of carbon dioxide (kPa) during insertion period - measured in arterial blood	14 hours
Arterial partial pressure (level) of oxygen	Arterial partial pressure of oxygen (kPa) during insertion period - measured in arterial blood	14 hours
Intramuscular partial pressure (level) of carbon dioxide	Intramuscular partial pressure of carbon dioxide (kPa) during insertion period - measured in the forearm	14 hours
Transcutaneous partial pressure (level) of carbon dioxide	Transcutaneous partial pressure of carbon dioxide (kPa) during insertion period, measured at the skin of the forehead	14 hours
Patient-Reported Outcome Measures 1a - discomfort	Discomfort in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 1b - discomfort	Discomfort in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 2a - runny nose	Runny nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 2b - runny nose	Runny nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 3a - sneezing	Sneezing - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 3b - sneezing	Sneezing - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 3b - Ulceration	Ulceration in the nose mucouse membrane - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 3a - Ulceration	Ulceration in the nose mucouse membrane - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 4a - tenderness	Tenderness in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 4b - tenderness	Tenderness in the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 5b - bleeding	Bleeding from the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 5a - bleeding	Bleeding from the nose - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 6a - reduced sense of smell	Reduced sense of smell - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 6b - reduced sense of smell	Reduced sense of smell - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 7b - reduced sense of taste	reduced sense of taste - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 7a - reduced sense of taste	reduced sense of taste - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 8a - difficulty sleeping	difficulty sleeping - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 8b - easy to wake up while sleeping	easy to wake up while sleeping - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	7 days
Patient-Reported Outcome Measures 9 - problems with eating and drinking	problems with eating and drinking - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 10 - difficult breathing	difficult breathing - Patient-Reported Outcome Measure, Scale 1 to 5 (1= no, 2= little, 3=Some, 4=very 5=Extreme)	14 hours
Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses	diagnosed infection in the nose or sinuses - Patient-Reported Outcome Measure, Scale 1 to 2 (1= No, 2= Yes)	14 hours
Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses	diagnosed infection in the nose or sinuses - Patient-Reported Outcome Measure, Scale 1 to 2 (1= No, 2= Yes)	7 days

Collaborators and Investigators

• Sponsor: The Hospital of Vestfold
• Collaborators: Sensocure AS
• Investigators: Principal Investigator: Anne-Marie Gabrielsen, MD, PhD, The Hospital of Vestfold

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: REK KULMU B 714179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No