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临床试验/NCT00653471
NCT00653471已完成1 期

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 Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年6月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Difference in endtidal PCO2 and PaCO2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Severe pulmonary disease
  • •Cardiac disease

研究组 & 干预措施

Obese osa

Active Comparator

Obese patients with osa

干预措施: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). (Device)

Obese osa

Active Comparator

Obese patients with osa

干预措施: Microcapmicro-stream device with Smart CapnoLine Plus (Device)

Obese osa

Active Comparator

Obese patients with osa

干预措施: Microcap micro-stream device with CapnoLine (Device)

Lean

Active Comparator

Lean patients

干预措施: Microcapmicro-stream device with Smart CapnoLine Plus (Device)

Lean

Active Comparator

Lean patients

干预措施: Microcap micro-stream device with CapnoLine (Device)

Lean

Active Comparator

Lean patients

干预措施: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). (Device)

Obese no OSA

Active Comparator

Obese patients without osa

干预措施: Microcapmicro-stream device with Smart CapnoLine Plus (Device)

Obese no OSA

Active Comparator

Obese patients without osa

干预措施: Microcap micro-stream device with CapnoLine (Device)

Obese no OSA

Active Comparator

Obese patients without osa

干预措施: TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). (Device)

结局指标

主要结局

Difference in endtidal PCO2 and PaCO2

时间窗: In PACU

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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