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

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.

Condition or disease Intervention/treatment Phase
COPD Healthy Subjects Device: sublingual silicon capillary Not Applicable

Detailed Description:

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. sublingual tonometric PCO2 - arterial PCO2 [ Time Frame: one year ]

Secondary Outcome Measures :
  1. sublingual tonometric PCO2 - PETCO2 [ Time Frame: one year ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • COPD patients with stable disease

Exclusion Criteria:

  • acute exacerbation of COPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01169506

Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged
Deszk, Hungary, 6772
Sponsors and Collaborators
Szeged University
Principal Investigator: Attila Somfay, MD,PhD Department of Pulmonology, University of Szeged, Hungary

Responsible Party: Attila Somfay, MD, PhD, Department of Pulmonology, University of Szeged, Hngary Identifier: NCT01169506     History of Changes
Other Study ID Numbers: nagymaci54
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: March 2009

Keywords provided by Szeged University:
blood gas analysis
ventilatory insufficiency

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs