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Completed

NCT Number: NCT00788788

Heliox in Experimental Upper Airway Obstruction

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.

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Key information

Conditions

Airway Obstruction Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

HELIOS-Klinikum / University of Witten/Herdecke

Wuppertal, North Rhine-Westphalia, 42283, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heliox

Drug

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

Primary outcomes

  1. Dyspnea score

    Time frame: Minutes

  2. Variability of systolic blood pressure

    Time frame: Minutes

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
First posted
Nov 11, 2008
Registry last updated
Nov 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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