Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor

Pulmonary Disease, Chronic Obstructive Clinical Trial

— DISCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367686
• Other study ID #: REK KULMU B 714179
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: The Hospital of Vestfold
• Contact: Anne-Marie Gabrielsen, MD, PhD
• Phone: 92485580
• Email: anne-marie.gabrielsen[@]siv.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 11
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• IscAlert sensor
Insertion of an IscAlert sensor at the nasal mucosa

Locations

Country	Name	City	State
Norway	Vestfold Hopsital Trust	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital of Vestfold	Sensocure AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscular temperature level	Muscular temperature level (grade Celsius) during insertion period	14 hours
Other	Nasal temperature level	Nasal temperature level (grade Celsius) during insertion period	14 hours
Other	Temporal temperature level	Temporal temperature level (grade Celsius) during insertion period	14 hours
Other	IscAlert functionality	Number of hours with a well-functioning sensor (giving carbon dioxide- and temperature data)	14 hours
Other	Number of pack-years	Smoking habit; number of pack-years by participants	7 days
Other	Length of sensor implantation time	Length of sensor implantation time during hospitalisation	7 days
Other	Peripheral oxygen saturation	Peripheral oxygen saturation (SpO2)	14 hours
Other	Arterial partial pressure (level) of carbon dioxide	Arterial partial pressure of carbon dioxide (kPa) during insertion period - measured in arterial blood	14 hours
Other	Arterial partial pressure (level) of oxygen	Arterial partial pressure of oxygen (kPa) during insertion period - measured in arterial blood	14 hours
Other	Intramuscular partial pressure (level) of carbon dioxide	Intramuscular partial pressure of carbon dioxide (kPa) during insertion period - measured in the forearm	14 hours
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	Bleeding	Amount of blood from insertion site (ml)	7 days
Secondary	Infection	Infection from insertion site at the discretion of the investigator (yes or no)	7 days
Secondary	Sinusitis	Developement of sinusitis at the discretion of the investigator (yes or no)	7 days
Secondary	Ulceration	Developement of ulceration at the nasal mucosa at the discretion of the investigator (yes or no)	7 days
Secondary	Pain at sensor insertion site	Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)	7 days