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Anwendung von HELIOX an einem Modell der oberen Atemwegsobstruktion

Anwendung von HELIOX an einem Modell der oberen Atemwegsobstruktion

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005289-37-DE
Enrollment
42
Registered
2007-08-16
Start date
2007-05-16
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A model of upper airway obstruction will be used to test the hypothesis that HELIOX 21 when additional oxygen is added (which is a common clinical situation) still can reduce the work of breathing. To test this hypothesis healty subjects will breath Heliox with additional oxygen for 2 minutes each through a resistive load.

Interventions

Trade Name: HELIOX21 Product Name: HELIOX21 Pharmaceutical Form: Inhalation gas Other descriptive name: Oxygen Concentration unit: % percent Concentration number: 25-75 Pharmaceutical form of the plac

Sponsors

University Witten/Herdecke
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy volunteers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any condition that renders the subject "not healthy". To exclude preganant women only subjects will be tested that demonstrate a negative pregnancy test on the day of study participation.

Design outcomes

Primary

MeasureTime frame
Main Objective: Test the hypothesis that HELIOX with lower Helium content still can reduce the work of breathing.;Secondary Objective: ;Primary end point(s): Measurement of heart rate, blood pressure (noninvasively using Finapress) and stroke volume (using noninvasive impedance thoracocardiography) that all show cyclic changes during loaded breathing and the reduction of these cyclic changes when the subject breathes HELIOX in a modell of upper airway obstruction.

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026