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

NCT00653471 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-20

No results posted yet for this study

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). 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.

Conditions

Interventions

DEVICE

Microcapmicro-stream device with Smart CapnoLine Plus

nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring

DEVICE

Microcap micro-stream device with CapnoLine

CO2 measured via nasal cannula

DEVICE

TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).

CO2 measured via nasal cannula

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Yusuke Kasuya, MD, PhD · University of Louisville School of Medicine

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-08-31
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653471 on ClinicalTrials.gov