Hubert Truebel1,2,3,4, Sandra Wuester5,6, Philip Boehme7,6, Hinnerk Doll6, Sven Schmiedl8,9,6, Jacek Szymanski8,9,6,10, Thorsten Langer11,12,6,13, Thomas Ostermann6, Dirk Cysarz6, Petra Thuermann8,9,6. 1. Department of Pediatrics, HELIOS Clinic Wuppertal, Wuppertal, Germany. hubert.truebel@bayer.com. 2. Department of Pediatrics, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. hubert.truebel@bayer.com. 3. Cardiovascular Research, Bayer Pharma AG, Apratherweg 18, 42096, Wuppertal, Germany. hubert.truebel@bayer.com. 4. School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. hubert.truebel@bayer.com. 5. Department of Pediatrics, HELIOS Clinic Schwelm, Schwelm, Germany. 6. School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. 7. Cardiovascular Research, Bayer Pharma AG, Apratherweg 18, 42096, Wuppertal, Germany. 8. Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany. 9. Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. 10. Medical Center City Region Aachen GmbH, Aachen, Germany. 11. Department of Pediatrics, HELIOS Clinic Wuppertal, Wuppertal, Germany. 12. Department of Pediatrics, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. 13. Department of Neuropediatrics and Muscle Disorders, Center for Pediatrics, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Abstract
BACKGROUND:Helium in oxygen (HELIOX) can relieve airway obstruction and lower the work of breathing because it increases the threshold at which turbulent gas flow is induced. Less turbulent and more laminar flow lowers the work of breathing. According to guidelines, the fraction of Helium in HELIOX should be maximized (e.g. to 79%). Here, we investigate whether HELIOX with less than 60% of Helium is able to relieve the sensation of dyspnea in healthy volunteers. METHODS:44 volunteers underwentresistive loading breathing different gases (medical air and HELIOX with a fraction of 25%, 50% or 75% helium in oxygen) in a double-blinded crossover design. Subjects rated their degree of dyspnea (primary outcome parameter) and the variability of noninvasively measured systolic blood pressure was assessed. RESULTS:Dyspnea was significantly reduced by HELIOX-containing mixtures with a fraction of helium of 25% or more. Similarly, blood pressure variability was reduced significantly even with helium 25% during respiratory loading with the higher load, whereas with the smaller load an effect could only be obtained with the highest helium fraction of 75%. CONCLUSION: In this clinical trial, HELIOX with less than 60% of helium in oxygen decreased the sensation of dyspnea and blood pressure variability, a surrogate parameter for airway obstruction. Therefore, higher oxygen fractions might be applied without losing the helium-related benefits for the treatment of upper airway obstruction. TRIAL REGISTRATION: Registration with clinical trials (NCT00788788) and EMA (EudraCT number: 2006-005289-37).
RCT Entities:
BACKGROUND:Helium in oxygen (HELIOX) can relieve airway obstruction and lower the work of breathing because it increases the threshold at which turbulent gas flow is induced. Less turbulent and more laminar flow lowers the work of breathing. According to guidelines, the fraction of Helium in HELIOX should be maximized (e.g. to 79%). Here, we investigate whether HELIOX with less than 60% of Helium is able to relieve the sensation of dyspnea in healthy volunteers. METHODS: 44 volunteers underwent resistive loading breathing different gases (medical air and HELIOX with a fraction of 25%, 50% or 75% helium in oxygen) in a double-blinded crossover design. Subjects rated their degree of dyspnea (primary outcome parameter) and the variability of noninvasively measured systolic blood pressure was assessed. RESULTS:Dyspnea was significantly reduced by HELIOX-containing mixtures with a fraction of helium of 25% or more. Similarly, blood pressure variability was reduced significantly even with helium 25% during respiratory loading with the higher load, whereas with the smaller load an effect could only be obtained with the highest helium fraction of 75%. CONCLUSION: In this clinical trial, HELIOX with less than 60% of helium in oxygen decreased the sensation of dyspnea and blood pressure variability, a surrogate parameter for airway obstruction. Therefore, higher oxygen fractions might be applied without losing the helium-related benefits for the treatment of upper airway obstruction. TRIAL REGISTRATION: Registration with clinical trials (NCT00788788) and EMA (EudraCT number: 2006-005289-37).
Entities:
Keywords:
Clinical proof-of-concept study; HELIOX; Upper airway obstruction; Work of breathing
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