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

July 18, 2016 updated by: The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Severe pulmonary disease
  • Cardiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lean
Lean patients
Device: Microcapmicro-stream device with Smart CapnoLine Plus
nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
Other Names:
  • Microcap, Oridion Capnography Inc., Needham, MA
  • TG-920, Nihon Kohden, Tokyo, Japan
  • conventional side-stream capnometers
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
Active Comparator: Obese no OSA
Obese patients without osa
Device: Microcapmicro-stream device with Smart CapnoLine Plus
nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
Other Names:
  • Microcap, Oridion Capnography Inc., Needham, MA
  • TG-920, Nihon Kohden, Tokyo, Japan
  • conventional side-stream capnometers
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
Active Comparator: Obese osa
Obese patients with osa
Device: Microcapmicro-stream device with Smart CapnoLine Plus
nasal oxygen mask tested to determine accuracy of endtidal CO2 monitoring
Other Names:
  • Microcap, Oridion Capnography Inc., Needham, MA
  • TG-920, Nihon Kohden, Tokyo, Japan
  • conventional side-stream capnometers
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in endtidal PCO2 and PaCO2
Time Frame: In PACU
In PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Yusuke Kasuya, MD, PhD, University of Louisville School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Capnography

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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