NCT00788788

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
Last Updated

November 21, 2008

Status Verified

November 1, 2008

Enrollment Period

1 month

First QC Date

November 10, 2008

Last Update Submit

November 20, 2008

Conditions

Airway ObstructionDyspnea

Keywords

Airway obstructionHelioxDifferent Helium content

Outcome Measures

Primary Outcomes (2)

  • Dyspnea score

    Minutes

  • Variability of systolic blood pressure

    Minutes

Study Arms (3)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

3

ACTIVE COMPARATOR

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

Interventions

HELIOXDRUG

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

123

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HELIOS-Klinikum / University of Witten/Herdecke

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30850876DERIVED

MeSH Terms

Conditions

Airway ObstructionDyspnea

Interventions

heliox

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hubert Trubel, MD

    University of Witten/Herdecke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Last Updated

November 21, 2008

Record last verified: 2008-11

Locations

DE(1)