The primary objective is to investigate whether the rebreathing apparatus or the steady-state apparatus should be used as a diagnostic tool in the MST. The primary objective is answer by means of sub questions, which involve; the repeatability of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the reproducibility of the measurements. This is
calculated by means of the ICC between the CO2 sensitivity slope of the first
and second measurement per method. Thus the ICC of S1R1-S1R2 and S1SS1-S1SS2.
Secondary outcome
Secondary endpoints are:
-The experiences of the subjects with both measurements
- Duration of the measurements
- Costs of the method (sum of the costs of the various part of each method +
costs of one long function analyst performing the measurement)
Background summary
Effects of increasing/decreasing levels of CO2 on ventilation can be studied
using the hypercapnic ventilatory response (HCVR). In various patient groups
the HCVR is disturbed. Two methods are known to measure the HCVR, the
rebreathing and steady-state method. Both methods can measure the ventilation
response to CO2, therefore in this study the two methods will be compared.
Computer controlled systems are not available for use, due to high costs to
persuade or built them. In this study two self-made apparatuses are built,
based on literature. The aim of the study is to find out which method is to be
implemented in the clinic, as a diagnostic tool, on basis of the repeatability
of both tests.
Study objective
The primary objective is to investigate whether the rebreathing apparatus or
the steady-state apparatus should be used as a diagnostic tool in the MST. The
primary objective is answer by means of sub questions, which involve; the
repeatability of both methods, experiences of the subjects, costs and time
duration of both methods.
Study design
The performed study has a diagnostic design, although the purpose of the study
is not to diagnose.
Intervention
nvt
Study burden and risks
The researched population does not benefit from participation in the study. In
contrast, MST and in particular the pulmonology department benefits from this
study. In both methods, high CO2 levels are maintained. The main risk of high
CO2 level can be decreased, by closely monitoring the CO2 level, to interrupt
the test when PETCO2 level are transcends 8.5 kPa or when the subject is not
feeling well. A potential risk of the steady-state method there is a risk of
inhalation of the CO2 absorber, which is overcome by placing an anti-bacterial
filter between the subject and the CO2 absorber canister. The risk of
inhalation harmful substances from the silicone parts is overcome by
sterilization of the silicone parts.
Koningsplein 1
Enschede 7521KZ
NL
Koningsplein 1
Enschede 7521KZ
NL
Listed location countries
Age
Inclusion criteria
between 18 and 65 years
written informed consent
Exclusion criteria
history of cardiopulmonary disease, neuromuscular disease, kyphoscoliosis
drug abuse
use of respiratory stimulants or depressants
pregnancy
unable to understand english or dutch
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL60541.044.17 |
OMON | NL-OMON28684 |