Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD) (subton)
|ClinicalTrials.gov Identifier: NCT01169506|
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : August 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD Healthy Subjects||Device: sublingual silicon capillary||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
|Experimental: COPD patients and healthy individuals||
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
- sublingual tonometric PCO2 - arterial PCO2 [ Time Frame: one year ]
- sublingual tonometric PCO2 - PETCO2 [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169506
|Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged|
|Deszk, Hungary, 6772|
|Principal Investigator:||Attila Somfay, MD,PhD||Department of Pulmonology, University of Szeged, Hungary|