COPDsubtonNCT01169506
Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing sublingual silicon capillary in people with COPD and Healthy Subjects, run by Szeged University at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy Subjects
- What is being tested?
- sublingual silicon capillary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHungary
- Study dates
- Aug 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- COPD patients with stable disease
Who cannot join
- acute exacerbation of COPD
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged
Deszk, 6772
About this study
Official title: A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals
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.
Read the 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.
- Conditions
- COPD, Healthy Subjects
- Being tested
- sublingual silicon capillary
- Keywords
- blood gas analysis, ventilatory insufficiency
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual silicon capillaryDevice
Also called sublingual tonometry, tissue perfusion, ventilation
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
| Study group | Role | What they receive |
|---|---|---|
| COPD patients and healthy individuals | Experimental | Not described Receives: Device: sublingual silicon capillary |
What is being measured
The primary outcome is the main question the study is designed to answer.
sublingual tonometric PCO2 - arterial PCO2
Measured: one year
Secondary outcomes (1)
sublingual tonometric PCO2 - PETCO2
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Investigators
- Attila Somfay, MD,PhD, Principal investigator, Department of Pulmonology, University of Szeged, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169506
- Sponsor's protocol ID
- nagymaci54
- Acronym
- subton
- Status last verified
- Mar 2009
- First submitted
- 23 Jul 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Boda D, Kaszaki J, Talosi 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. doi: 10.1017/S026502150600055X.
PubMed 16805933
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals
- ClinicalTrials.gov ID
- NCT01169506
- Acronym / sponsor ID
- subton / nagymaci54
- Conditions
- COPD, Healthy Subjects
- Keywords
- blood gas analysis, ventilatory insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients and healthy individuals | Experimental | Device: sublingual silicon capillary |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients with stable disease
Key exclusion criteria (1 listed)
- acute exacerbation of COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sublingual silicon capillaryAlso: sublingual tonometry, tissue perfusion, ventilationStable 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 | Device | COPD patients and healthy individuals |
Primary outcome
sublingual tonometric PCO2 - arterial PCO2
Time frame: one year
1 secondary outcome
sublingual tonometric PCO2 - PETCO2
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2010.
- Background: PubMed 16805933Boda D, Kaszaki J, Talosi 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. doi: 10.1017/S026502150600055X.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attila Somfay, MD,PhD principal investigator
Department of Pulmonology, University of Szeged, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sublingual silicon capillary in people with COPD and Healthy Subjects, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sublingual tonometric PCO2 - arterial PCO2 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01169506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2010.