Heliox in Experimental Upper Airway Obstruction

Dyspnea Clinical Trial

Official title:

PoC Study of Heliox With Helium-Fractions Between 25 and 75% in Experimental Upper Airway Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788788
• Other study ID #: Heliox-PoC
• Secondary ID: EudraCT-No. 2006
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 10, 2008
• Last updated: November 20, 2008
• Start date: November 2007

Study information

• Verified date: November 2008
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Volunteers of both sexes were recruited via posting in student forum of University of Witten/Herdecke

• Willingness to spend about 2h in the clinical exp. lab.

Exclusion Criteria:

• Acute airway infection

• History of asthma

• Smokers

• Pregnancy

• Abnormal lab. screen with liver function tests, Creat./BUN, CBC, blood glucose

• Anxiety or mood disorder

• Any chronic disease (incl. lung & heart disease, cancer, endocrine disorder)

• Mental retardation

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

• Airway Obstruction
• Dyspnea

Intervention

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

Locations

Country	Name	City	State
Germany	HELIOS-Klinikum / University of Witten/Herdecke	Wuppertal	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea score		Minutes	No
Primary	Variability of systolic blood pressure		Minutes	No