Heliox in Experimental Upper Airway Obstruction

This study has been completed.
Sponsor:
Information provided by:
University of Witten/Herdecke
ClinicalTrials.gov Identifier:
NCT00788788
First received: November 10, 2008
Last updated: November 20, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Airway Obstruction
Dyspnea
Drug: HELIOX
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PoC Study of Heliox With Helium-Fractions Between 25 and 75% in Experimental Upper Airway Obstruction

Resource links provided by NLM:


Further study details as provided by University of Witten/Herdecke:

Primary Outcome Measures:
  • Dyspnea score [ Time Frame: Minutes ] [ Designated as safety issue: No ]
  • Variability of systolic blood pressure [ Time Frame: Minutes ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
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
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
Active Comparator: 3
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788788

Locations
Germany
HELIOS-Klinikum / University of Witten/Herdecke
Wuppertal, NRW, Germany, 42283
Sponsors and Collaborators
University of Witten/Herdecke
Investigators
Principal Investigator: Hubert Trubel, MD University of Witten/Herdecke
  More Information

No publications provided

Responsible Party: Dr. Hubert Trubel, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT00788788     History of Changes
Other Study ID Numbers: Heliox-PoC, EudraCT-No. 2006-005289-37
Study First Received: November 10, 2008
Last Updated: November 20, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Witten/Herdecke:
Airway obstruction
Heliox
Different Helium content

Additional relevant MeSH terms:
Airway Obstruction
Dyspnea
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014