Micro-Stream Capnography in Non-Intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00653471
First received: February 19, 2008
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Obesity
Obstructive Sleep Apnea
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).
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • Difference in endtidal PCO2 and PaCO2 [ Time Frame: In PACU ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653471

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Yusuke Kasuya, MD, PhD University of Louisville School of Medicine
  More Information

No publications provided

Responsible Party: Yusuke Kasuya, University of Louisville
ClinicalTrials.gov Identifier: NCT00653471     History of Changes
Other Study ID Numbers: Capnography
Study First Received: February 19, 2008
Last Updated: September 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
obesity
osa
capnography
general anesthesia

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014