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

Sponsor
Szeged University (Other)
Overall Status
Completed
CT.gov ID
NCT01169506
Collaborator
(none)
66
Enrollment
1
Location
1
Arm
10
Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: sublingual silicon capillary
 N/A

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 Design

Study Type:
Interventional
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 :
Aug 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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 Names:
  • sublingual tonometry, tissue perfusion, ventilation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sublingual tonometric PCO2 - arterial PCO2 [one year]

    Secondary Outcome Measures

    1. sublingual tonometric PCO2 - PETCO2 [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • COPD patients with stable disease
    Exclusion Criteria:
    • acute exacerbation of COPD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01169506
    Other Study ID Numbers:
    • nagymaci54
    First Posted:
    Jul 26, 2010
    Last Update Posted:
    Aug 9, 2010
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    blood gas analysis
    ventilatory insufficiency
    Additional relevant MeSH terms:
    Silicon

    Study Results

    No Results Posted as of Aug 9, 2010