Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea

Completed · Early Phase 1

Conditions studied: Obesity, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT00653471

Run by

The Cleveland Clinic

People needed

60

Starts

2006-06-01

Expected to finish

2008-09-01

Last updated by the study team

2016-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Severe pulmonary disease
• Cardiac disease

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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