NCT01762917

Brief Summary

Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag) is proposed by the system, however, elderly patients or those suffering from high grade pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to completely mix the test gases. The aim of our study is to evaluate the effect of adapting Vbag on the reproducibility of IGR measurements in patients with obstruction (group A), restriction (group B) and pulmonary healthy controls (group C).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

December 21, 2012

Last Update Submit

January 7, 2013

Conditions

Chronic Obstructive Pulmonary DiseaseBronchial AsthmaRestrictive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • pulmonary blood flow

    variation of serial pulmonary blood flow measurements

    1 day

Study Arms (3)

Obstruction

Patients suffering from pulmonary obstruction

Restriction

Patients suffering from pulmonary restriction

Controls

Pulmonary healthy controls

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

inpatients and outpatients, internal medicine, university hospital

You may qualify if:

  • ability to perform rebreathing maneuver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Mannheim

Mannheim, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 8, 2013

Study Start

September 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

DE(1)