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Measurement of changes in ventilation at various levels of inspired carbon dioxide with two methodes.


- candidate number26739
- NTR NumberNTR6254
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2017
- Secondary IDsNL6054104417 
- Public TitleMeasurement of changes in ventilation at various levels of inspired carbon dioxide with two methodes.
- Scientific TitleThe hypercapnic ventilatory response measured with a rebreathing and steady-state apparatus in healthy subjects
- ACRONYMHCVR study
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers
- Inclusion criteriahealthy, adult aged between 18 and 65
- Exclusion criteriahistory of cardio-pulmonary disease, neuro(muscular) disease, and/or kyphoscoliosis; unable to understand and read the English or Dutch language; drug abuse; use of respiratory stimulants or depressant; and pregnant women
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 22-mrt-2017
- planned closingdate1-sep-2017
- Target number of participants20
- Interventionsnot applicable
- Primary outcomeThe 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) - minimal CO2 in rebreathing technique
- Timepoints-
- Trial web site-
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESD.C. Mannée
- CONTACT for SCIENTIFIC QUERIESD.C. Mannée
- Sponsor/Initiator MST Enschede
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- Publications
- Brief summaryEffects 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.
- Main changes (audit trail)7-mei-2017 - MT

Added target number of participants: 20 subjects

Primary outcome replaced by:
The main study endpoint is the reproducibility of the measurements. Sensitivity slope (L/min per kPa) of the curve is calculated by means of linear regression. To assess the repeatability of both methods, the ICC is calculated between the paired CO2 sensitivity slopes of the first and second rebreathing measurement and between the first and second steady-state measurement.

Added timepoints:
Measurements are performed with 20 subjects. Two appointments per subject are made, the second measurement is within 5-9 days after the first. At both appointments HCVR is measured with both methods. At the first appointment the order is determined with a randomisation list (rebreathing steady-state or steady-state rebreathing).

Start date 1 april 2017 replaced by 22 march 2017
- RECORD6-mrt-2017 - 3-sep-2017


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