A Phase 1/2 interventional study of HELIOX in Airway Obstruction and Dyspnea, sponsored by University of Witten/Herdecke. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-11-21.
Sponsored by University of Witten/Herdecke · Phase 1/2, Interventional, and Treatment
Currently it is common medical wisdom that HELIOX (mixture of Helium in Oxygen) with a fraction of Helium below 60% is not effective in reducing airway obstruction. The investigators test the hypothesis that HELIOX with a fraction of Helium below 60% is still effective in relieving airway obstruction in a double-blind, randomized and controlled clinical PoC study with experimental upper airway obstruction.
HELIOX is a mixture of Helium and Oxygen. It is a therapeutic modality that can improve upper and lower airway obstruction. The lower density of Helium can help to relieve airway obstruction and is known to lower the work of breathing. The fraction of Helium (FHe) in HELIOX should be maximized (e.g. up to a fraction of 79% with 21% of oxygen added) in order to achieve optimal anti-obstructive outcome and according to the literature a FHe below 60% renders HELIOX ineffective.
Objective: We conducted an investigator-initiated trial using different mixtures of Helium and Oxygen in 44 healthy volunteers in a randomized and double-blinded fashion.
Methods: After an adjustment phase the subjects were breathing through two different external resistors (intratracheal tube with inner diameter of either 4.0mm or 5.0mm) while gas of different composition (medical air with 79% Nitrogen and 21% Oxygen as control gas and HELIOX with a fraction of either 25%, 50% or 75% Helium in Oxygen, respectively) was provided in a blinded and random fashion. A crossover design was used so that every subject was exposed to every HELIOX gas mixture. Subjects were asked to score their degree of dyspnea after breathing different gas mixtures for 2 minutes intervals. In addition the variability of different hemodynamic parameters was assessed (continuous non-invasive blood pressure (systolic, diastolic and mean blood pressure), impedance cardiography (stroke volume and cardiac output), ECG (heart rate variability)) were assessed non-invasively and used to detected a change in the degree of airway obstruction in respect to the added load and the gas mixture.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 44 is close to the median of 48 across 430 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →University of Witten/Herdecke is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study subjects where breathing Heliox with a fraction of Helium of 25% followed by 50% and 75% with larger external resistor in comparison to medical air
Drug: HELIOX
Study subjects where breathing Heliox with a fraction of Helium of 50% followed by 75% and 25% with larger external resistor in comparison to medical air
Drug: HELIOX
Study subjects where breathing Heliox with a fraction of Helium of 25% followed by 50% and 75% with larger external resistor in comparison to medical air
Drug: HELIOX
HELIOX is a mixture of Helium in Oxygen with a low density and the ability to reduce the work of breathing in subjects with airway obstruction. The fractions of Helium was altered in a different order depending on the arm of the study
Dyspnea score
Time frame: Minutes
Variability of systolic blood pressure
Time frame: Minutes
This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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University of Witten/Herdecke