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

COPD Clinical Trial

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Official title:

A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169506
• Other study ID #: nagymaci54
• Status: Completed
• Phase: N/A
• First received: July 23, 2010
• Last updated: August 6, 2010
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: March 2009
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• COPD patients with stable disease

Exclusion Criteria:

• acute exacerbation of COPD

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• COPD
• Healthy Subjects
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Hungary	Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged	Deszk

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sublingual tonometric PCO2 - arterial PCO2		one year	No
Secondary	sublingual tonometric PCO2 - PETCO2		one year	No