Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD) (subton)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01169506
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : August 9, 2010
Information provided by:
Szeged University

July 23, 2010
July 26, 2010
August 9, 2010
August 2009
June 2010   (Final data collection date for primary outcome measure)
sublingual tonometric PCO2 - arterial PCO2 [ Time Frame: one year ]
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Complete list of historical versions of study NCT01169506 on Archive Site
sublingual tonometric PCO2 - PETCO2 [ Time Frame: one year ]
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Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals

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.

We have developed a new silicon capillary system for sublingual monitoring of CO2 tension in order to assess tissue perfusion. This set up is non-invasive, cheaper than previous tonometry devices and easier to apply in clinical routine. We have recruited patients with stable COPD and healthy individuals.

Sublingual tonometry results were evaluated after 15 min of tidal breathing with a capnometer for CO2 tension. Corresponding end tidal CO2 (PETCO2)and arterial blood gas values (pH, PaCO2, PaCO2) were also investigated.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • COPD
  • Healthy Subjects
Device: sublingual silicon capillary
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
Other Name: sublingual tonometry, tissue perfusion, ventilation
Experimental: COPD patients and healthy individuals
Intervention: Device: sublingual silicon capillary
Boda D, Kaszaki J, Tálosi 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • COPD patients with stable disease

Exclusion Criteria:

  • acute exacerbation of COPD
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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Attila Somfay, MD, PhD, Department of Pulmonology, University of Szeged, Hngary
Szeged University
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Principal Investigator: Attila Somfay, MD,PhD Department of Pulmonology, University of Szeged, Hungary
Szeged University
March 2009

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