Hypercapnic Respiratory Failure, Neuromuscular Diseases, Obesity Hypoventilation Syndrome (OHS), Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DEVICEIscAlert sensor
Insertion of an IscAlert sensor at the nasal mucosa
Sponsors
The Hospital of Vestfold
Sensocure AS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial pressure (level) of carbon dioxide at the nasal mucosa | 14 hours | Nasal mucosa's partial pressure of carbon dioxide (kPa) during insertion period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 7 days | Amount of blood from insertion site (ml) |
| Infection | 7 days | Infection from insertion site at the discretion of the investigator (yes or no) |
| Sinusitis | 7 days | Developement of sinusitis at the discretion of the investigator (yes or no) |
| Ulceration | 7 days | Developement of ulceration at the nasal mucosa at the discretion of the investigator (yes or no) |
| Pain at sensor insertion site | 7 days | Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain) |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORAnne-Marie Gabrielsen, MD, PhD
The Hospital of Vestfold
Outcome results
None listed