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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06367686
Other study ID # REK KULMU B 714179
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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