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
  Purpose

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 Intervention
COPD
Healthy Subjects
Device: sublingual silicon capillary

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals

Resource links provided by NLM:


Further study details as provided by Szeged University:

Primary Outcome Measures:
  • sublingual tonometric PCO2 - arterial PCO2 [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sublingual tonometric PCO2 - PETCO2 [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • COPD patients with stable disease

Exclusion Criteria:

  • acute exacerbation of COPD
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01169506

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

Publications:
Responsible Party: Attila Somfay, MD, PhD, Department of Pulmonology, University of Szeged, Hngary
ClinicalTrials.gov Identifier: NCT01169506     History of Changes
Other Study ID Numbers: nagymaci54
Study First Received: July 23, 2010
Last Updated: August 6, 2010
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Szeged University:
blood gas analysis
ventilatory insufficiency

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

ClinicalTrials.gov processed this record on August 28, 2014