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临床试验/NCT06367686
NCT06367686已完成不适用

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

The Hospital of Vestfold2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Partial pressure (level) of carbon dioxide at the nasal mucosa

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subject must meet all of the following inclusion criteria at the time of enrolment:
  • Patient are at risk of hypoventilation and thus carbon dioxide retention.
  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 14 hours

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

次要结局

  • Pain at sensor insertion site(7 days)
  • Infection(7 days)
  • Bleeding(7 days)
  • Sinusitis(7 days)
  • Ulceration(7 days)

研究者

发起方
The Hospital of Vestfold
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne-Marie Gabrielsen

Senior consultant

The Hospital of Vestfold

研究点 (2)

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