Dyspnea Clinical Trial - Heliox in Experimental Upper Airway Obstruction

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00788788
Study type	Interventional
Source	University of Witten/Herdecke
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	November 2007

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04688905` - Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
Completed	`NCT03679312` - The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD	Phase 1/Phase 2
Recruiting	`NCT04868357` - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program	N/A
Active, not recruiting	`NCT03604822` - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS	N/A
Completed	`NCT03626519` - Effects of Menthol on Dyspnoea in COPD Patients	N/A
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed	`NCT02248831` - Evaluation of Cardiopulmonary Diseases by Ultrasound	N/A
Terminated	`NCT02269761` - Chest Ultrasound of ER Patients With Cough or SOB
Completed	`NCT02538770` - Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization	N/A
Recruiting	`NCT01655199` - Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease	N/A
Active, not recruiting	`NCT01440764` - Aerosol Inhalation Treatment for Dyspnea	Phase 1/Phase 2
Completed	`NCT01577407` - Non Opioid Treatment for Experimental Dyspnea	Phase 3
Completed	`NCT01193998` - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department	N/A
Recruiting	`NCT04327882` - Point-of-care Ultrasound Interest in Dyspneic Emergency Department Patients: an Observational Bicentric Study
Completed	`NCT05029986` - Preventing Dyspnea During Speech in Older Speakers	N/A
Not yet recruiting	`NCT04181359` - The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease.	Phase 1/Phase 2
Recruiting	`NCT04615065` - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed	`NCT04305639` - The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
Completed	`NCT04370990` - Automated Oxygen Administration -Rethinking Interventions Alleviating Dyspnea in Patients With COPD	N/A
Completed	`NCT04375917` - Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.