Heliox in Experimental Upper Airway Obstruction

NCT ID: NCT00788788

Last Updated: 2008-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

Brief 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.

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.

Conditions

Airway Obstruction; Dyspnea

Keywords

Airway obstruction; Heliox; Different Helium content

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

HELIOX

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

HELIOX

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

HELIOX

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

University of Witten/Herdecke

Principal Investigators

Hubert Trubel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Witten/Herdecke

Locations

HELIOS-Klinikum / University of Witten/Herdecke

Wuppertal, North Rhine-Westphalia, Germany

Countries

Germany

References

Truebel H, Wuester S, Boehme P, Doll H, Schmiedl S, Szymanski J, Langer T, Ostermann T, Cysarz D, Thuermann P. A proof-of-concept trial of HELIOX with different fractions of helium in a human study modeling upper airway obstruction. Eur J Appl Physiol. 2019 May;119(5):1253-1260. doi: 10.1007/s00421-019-04116-7. Epub 2019 Mar 8.

Reference Type: DERIVED

PMID: 30850876 (View on PubMed)

Other Identifiers

EudraCT-No. 2006-005289-37

Identifier Type: -

Identifier Source: secondary_id

Heliox-PoC

Identifier Type: -

Identifier Source: org_study_id