Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD)
subton
A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals
1 other identifier
interventional
66
1 country
1
Brief Summary
Sublingual positioning of a silicon capillary system is applied. After 15 min, while the individual is in resting position with closed mouth and normal tidal breathing through the nose is performed, the silicon capillary system is connected to a capnometer and CO2 tension is measured. The investigators hypothesis is that this setup offers a non-invasive assessment of ventilatory efficiency with similar accuracy as arterial PCO2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
1 active site
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
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 23, 2010
CompletedFirst Posted
Study publicly available on registry
July 26, 2010
CompletedAugust 9, 2010
March 1, 2009
10 months
July 23, 2010
August 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sublingual tonometric PCO2 - arterial PCO2
one year
Secondary Outcomes (1)
sublingual tonometric PCO2 - PETCO2
one year
Study Arms (1)
COPD patients and healthy individuals
EXPERIMENTALInterventions
Stable patients with COPD and healthy individuals were asked to open their mouth and a small butterfly silicon capillary was placed sublingually. After 15 minutes, while the mouth was closed completely and nose breathing was performed, the capillary system was connected to a capnometer and sublingual tonometric PCO2 was measured. At the same time, PETCO2 was also measured and arterial blood was drawn for pH, PO2 and PCO2 analysis
Eligibility Criteria
You may qualify if:
- COPD patients with stable disease
You may not qualify if:
- acute exacerbation of COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged
Deszk, 6772, Hungary
Related Publications (1)
Boda D, Kaszaki J, Talosi G. A new simple tool for tonometric determination of the PCO2 in the gastrointestinal tract: in vitro and in vivo validation studies. Eur J Anaesthesiol. 2006 Aug;23(8):680-5. doi: 10.1017/S026502150600055X.
PMID: 16805933BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Attila Somfay, MD,PhD
Department of Pulmonology, University of Szeged, Hungary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 23, 2010
First Posted
July 26, 2010
Study Start
August 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
August 9, 2010
Record last verified: 2009-03