ObesityEarly Phase 1NCT00653471
Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea
A Early Phase 1 study testing Microcapmicro-stream device with Smart CapnoLine Plus, Microcap micro-stream device with CapnoLine and TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). in people with Obesity and Obstructive Sleep Apnea, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea
- What is being tested?
- Microcapmicro-stream device with Smart CapnoLine Plus, Microcap micro-stream device with CapnoLine and TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2008
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal weight patients (defined as BMI < 30 kg/m2) without a diagnosis of OSA
- 20 obese patients (BMI > 35 kg/m2) without a diagnosis of OSA
- 20 obese patients with polysomnography-diagnosed OSA
Who cannot join
- Severe pulmonary disease
- Cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: The Accuracy of End-tidal PCO2 Measurements With Main-stream and Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea
The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of non-intubated, spontaneously breathing patients will be included: 1) lean patients without obstructive sleep apnea (OSA); 2) obese patients without OSA; and 3) obese patients diagnosed with OSA. This latter group has a higher prevalence of oral breathing.
Additionally, to test the efficacy of oral guides, we propose to compare the accuracy of EtPCO2 measurements from the Microcap with two different nasal cannulas, one with (Smart CapnoLine PlusTM, Oridion Medical, Jerusalem, Israel) and one without (CapnoLineTM H, Oridion Medical) an oral guide to trap gas expired from the mouth. The TG-920 main-stream system requires its purpose-designed YG-122T cannula so that is the only one that will be tested with the Nihon-Kohden product.
Read the detailed description
After institutional review board approval and informed consent, we will recruit 60 patients who are scheduled for general anesthesia: 20 normal weight patients (defined as BMI < 30 kg/m2) without a diagnosis of OSA, 20 obese patients (BMI > 35 kg/m2) without a diagnosis of OSA, and 20 obese patients with polysomnography-diagnosed OSA. Patients with known severe pulmonary or cardiac disease will be excluded.
Protocol Patients will be given general anesthesia with endotracheal intubation or a laryngeal mask airway. In the post-anesthesia care unit, they will be given oxygen through a nasal cannula. They will be randomly assigned to one of two capnometers: Microcap (Oridion Capnography Inc., Needham, MA) or TG-920 (Nihon Kohden, Tokyo, Japan) with O2 administered at 3 L/min. The order of application of the two capnometers will be randomized according to computer-generated codes kept in opaque envelopes until the study begins. The order of the two nasal cannulas for the Microcap (Oridion Capnography Inc., Needham, MA) will also be randomized.
Thus, each patient will have their EtCO2 values measured under three conditions: with the Microcap capnometer via the Smart CapnoLine PlusTM cannula at 3 L/min O2 flow; with the Microcap capnometer via the CapnoLineTM H cannula at 3 L/min O2 flow; and with the TG-920 capnometer with 3 L/min O2 flow. EtCO2 will be measured for 5 minutes with each device and cannula. At the end of the 5-min sampling period (5 minutes after start of each capnometer and nasal cannula combination), 2-3 ml arterial blood will be drawn to obtain blood gas measurements. This blood sample will be obtained from an indwelling radial arterial catheter that will be inserted pre-, intra-, or postoperatively by the attending anesthesiologist, the resident in charge of the case, or one of our investigators. After the blood gas samples are collected, another capnometer will be applied and the same procedure will be repeated. When the capnometers or cannulas are changed, the patients will be asked to rate their comfort level.
At the beginning of each sampling period for each capnometer and nasal cannula combination, an Angiocath, which will be connected to the capnometer, will be applied to nostrils and presence or absence of nasal breathing will be recorded. The capnometers and arterial blood gas analyzer will be calibrated before each experiment according to the manufacturer's instructions.
Measurements Morphometric and demographic characteristics of the participating patients will be recorded. Our major outcomes will be accuracy of EtCO2 values with each capnometer during administration of 3 L/min O2 in non-obese patients without OSA, obese patients without OSA, and obese patients with OSA. In each patient, during the 5-min application of each combination of capnometer and nasal cannula, EtCO2 values will be measured for 5 minutes and averaged. These averaged EtCO2 values for each set will be subtracted from the arterial partial pressure of carbon dioxide (PaCO2) value measured simultaneously ( GEM Premier 3000, Instrumentation Laboratory, Lexington, MA). At nominal value of PaCO2 at 34 mmHg, precision and accuracy of PaCO2 measurement by GEM Premier 3000are 1 mmHg and 0.15 mmHg, respectively. Our minor outcomes will be oxygenation efficacy and patient's comfort with the three nasal cannulas. The arterial partial oxygen pressure (PaO2) will be measured ( GEM Premier 3000, Instrumentation Laboratory, Lexington, MA) for each nasal cannula. Patients will rate their comfort level on a 10-cm visual analogue scale (VAS) for each nasal cannula.
- Conditions
- Obesity, Obstructive Sleep Apnea
- Being tested
- Microcapmicro-stream device with Smart CapnoLine Plus, Microcap micro-stream device with CapnoLine, TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).
- Keywords
- obesity, osa, capnography, general anesthesia
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcapmicro-stream device with Smart CapnoLine PlusDevice
Also called Microcap, Oridion Capnography Inc., Needham, MA, TG-920, Nihon Kohden, Tokyo, Japan, conventional side-stream capnometers
nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
Microcap micro-stream device with CapnoLineDevice
CO2 measured via nasal cannula
TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).Device
CO2 measured via nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Lean | Active comparator | Lean patients Receives: Device: Microcapmicro-stream device with Smart CapnoLine Plus; Device: Microcap micro-stream device with CapnoLine; Device: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). |
| Obese no OSA | Active comparator | Obese patients without osa Receives: Device: Microcapmicro-stream device with Smart CapnoLine Plus; Device: Microcap micro-stream device with CapnoLine; Device: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). |
| Obese osa | Active comparator | Obese patients with osa Receives: Device: Microcapmicro-stream device with Smart CapnoLine Plus; Device: Microcap micro-stream device with CapnoLine; Device: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in endtidal PCO2 and PaCO2
Measured: In PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startJun 2006
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yusuke Kasuya, MD, PhD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653471
- Sponsor's protocol ID
- Capnography
- Status last verified
- Jul 2016
- First submitted
- 19 Feb 2008
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of End-tidal PCO2 Measurements With Main-stream and Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00653471
- Acronym / sponsor ID
- Capnography
- Conditions
- Obesity, Obstructive Sleep Apnea
- Keywords
- obesity, osa, capnography, general anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Apr 2008 (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.
The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of non-intubated, spontaneously breathing patients will be included: 1) lean patients without obstructive sleep apnea (OSA); 2) obese patients without OSA; and 3) obese patients diagnosed with OSA. This latter group has a higher prevalence of oral breathing.
Additionally, to test the efficacy of oral guides, we propose to compare the accuracy of EtPCO2 measurements from the Microcap with two different nasal cannulas, one with (Smart CapnoLine PlusTM, Oridion Medical, Jerusalem, Israel) and one without (CapnoLineTM H, Oridion Medical) an oral guide to trap gas expired from the mouth. The TG-920 main-stream system requires its purpose-designed YG-122T cannula so that is the only one that will be tested with the Nihon-Kohden product.
Detailed description
After institutional review board approval and informed consent, we will recruit 60 patients who are scheduled for general anesthesia: 20 normal weight patients (defined as BMI < 30 kg/m2) without a diagnosis of OSA, 20 obese patients (BMI > 35 kg/m2) without a diagnosis of OSA, and 20 obese patients with polysomnography-diagnosed OSA. Patients with known severe pulmonary or cardiac disease will be excluded.
Protocol Patients will be given general anesthesia with endotracheal intubation or a laryngeal mask airway. In the post-anesthesia care unit, they will be given oxygen through a nasal cannula. They will be randomly assigned to one of two capnometers: Microcap (Oridion Capnography Inc., Needham, MA) or TG-920 (Nihon Kohden, Tokyo, Japan) with O2 administered at 3 L/min. The order of application of the two capnometers will be randomized according to computer-generated codes kept in opaque envelopes until the study begins. The order of the two nasal cannulas for the Microcap (Oridion Capnography Inc., Needham, MA) will also be randomized.
Thus, each patient will have their EtCO2 values measured under three conditions: with the Microcap capnometer via the Smart CapnoLine PlusTM cannula at 3 L/min O2 flow; with the Microcap capnometer via the CapnoLineTM H cannula at 3 L/min O2 flow; and with the TG-920 capnometer with 3 L/min O2 flow. EtCO2 will be measured for 5 minutes with each device and cannula. At the end of the 5-min sampling period (5 minutes after start of each capnometer and nasal cannula combination), 2-3 ml arterial blood will be drawn to obtain blood gas measurements. This blood sample will be obtained from an indwelling radial arterial catheter that will be inserted pre-, intra-, or postoperatively by the attending anesthesiologist, the resident in charge of the case, or one of our investigators. After the blood gas samples are collected, another capnometer will be applied and the same procedure will be repeated. When the capnometers or cannulas are changed, the patients will be asked to rate their comfort level.
At the beginning of each sampling period for each capnometer and nasal cannula combination, an Angiocath, which will be connected to the capnometer, will be applied to nostrils and presence or absence of nasal breathing will be recorded. The capnometers and arterial blood gas analyzer will be calibrated before each experiment according to the manufacturer's instructions.
Measurements Morphometric and demographic characteristics of the participating patients will be recorded. Our major outcomes will be accuracy of EtCO2 values with each capnometer during administration of 3 L/min O2 in non-obese patients without OSA, obese patients without OSA, and obese patients with OSA. In each patient, during the 5-min application of each combination of capnometer and nasal cannula, EtCO2 values will be measured for 5 minutes and averaged. These averaged EtCO2 values for each set will be subtracted from the arterial partial pressure of carbon dioxide (PaCO2) value measured simultaneously ( GEM Premier 3000, Instrumentation Laboratory, Lexington, MA). At nominal value of PaCO2 at 34 mmHg, precision and accuracy of PaCO2 measurement by GEM Premier 3000are 1 mmHg and 0.15 mmHg, respectively. Our minor outcomes will be oxygenation efficacy and patient's comfort with the three nasal cannulas. The arterial partial oxygen pressure (PaO2) will be measured ( GEM Premier 3000, Instrumentation Laboratory, Lexington, MA) for each nasal cannula. Patients will rate their comfort level on a 10-cm visual analogue scale (VAS) for each nasal cannula.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean | Active comparator | Device: Microcapmicro-stream device with Smart CapnoLine Plus, Device: Microcap micro-stream device with CapnoLine, Device: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).Lean patients |
| Obese no OSA | Active comparator | Device: Microcapmicro-stream device with Smart CapnoLine Plus, Device: Microcap micro-stream device with CapnoLine, Device: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).Obese patients without osa |
| Obese osa | Active comparator | Device: Microcapmicro-stream device with Smart CapnoLine Plus, Device: Microcap micro-stream device with CapnoLine, Device: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).Obese patients with osa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal weight patients (defined as BMI < 30 kg/m2) without a diagnosis of OSA
- 20 obese patients (BMI > 35 kg/m2) without a diagnosis of OSA
- 20 obese patients with polysomnography-diagnosed OSA
Key exclusion criteria (2 listed)
- Severe pulmonary disease
- Cardiac disease
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 |
|---|---|---|
| Microcapmicro-stream device with Smart CapnoLine PlusAlso: Microcap, Oridion Capnography Inc., Needham, MA, TG-920, Nihon Kohden, Tokyo, Japan, conventional side-stream capnometersnasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring | Device | Lean, Obese no OSA, Obese osa |
| Microcap micro-stream device with CapnoLineCO2 measured via nasal cannula | Device | Lean, Obese no OSA, Obese osa |
| TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).CO2 measured via nasal cannula | Device | Lean, Obese no OSA, Obese osa |
Primary outcome
Difference in endtidal PCO2 and PaCO2
Time frame: In PACU
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 20 Jul 2016.
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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.
Yusuke Kasuya, MD, PhD principal investigator
University of Louisville School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microcapmicro-stream device with Smart CapnoLine Plus, Microcap micro-stream device with CapnoLine and TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). in people with Obesity and Obstructive Sleep Apnea, run by The Cleveland Clinic at 1 site in United States.
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 3 inclusion and 2 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 20 Jul 2016. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in endtidal PCO2 and PaCO2 (time frame: In PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2016.