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

This study has been completed.
Sponsor:
Information provided by:
Szeged University
ClinicalTrials.gov Identifier:
NCT01169506
First received: July 23, 2010
Last updated: August 6, 2010
Last verified: March 2009
History of Changes

July 23, 2010
August 6, 2010
August 2009
June 2010   (final data collection date for primary outcome measure)
sublingual tonometric PCO2 - arterial PCO2 [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01169506 on ClinicalTrials.gov Archive Site
sublingual tonometric PCO2 - PETCO2 [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01169506
nagymaci54
No
Attila Somfay, MD, PhD, Department of Pulmonology, University of Szeged, Hngary
Szeged University
Not Provided
Principal Investigator: Attila Somfay, MD,PhD Department of Pulmonology, University of Szeged, Hungary
Szeged University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP