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临床试验/NCT02523586
NCT02523586已完成不适用

Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor

研究概览

简要总结

The intent of this study is to determine the difference in pharyngeal oxygen concentration in patients who have a natural airway (not intubated) using commonly available oxygen delivery systems.

The investigators will test the hypothesis that oxygen concentration during the period of inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit.

A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%. With a significance criterion of 0.05, 10 subjects would provide more than 90% power to detect a mean difference of 10%.

详细描述

Oxygen therapy refers to the administration of oxygen at higher concentrations than room air. According to the most recent American Association for Respiratory Care Clinical Practice Guidelines, indications for supplemental oxygen include hypoxemia, severe trauma, acute myocardial infarction, short term therapy, and postoperative recovery. Though there are few contraindications to oxygen therapy, potential complications exist, including ventilatory depression in hypercarbic patients, absorption atelectasis, and oxygen toxicity (particularly in some patients receiving specific chemotherapeutic agents). In the spontaneously breathing hypoxemic patient without an endotracheal tube, it is important to be able to deliver high concentrations of oxygen in order to either avoid intubation or bridge to intubation. A number of oxygen delivery devices are available that have different properties that make them useful for different situations.

Variable performance (low-flow) systems: Low-flow devices are variable performance because the delivered flow rates are less than the patient's peak inspiratory flow rate (PIFR) and the oxygen is diluted by room air entrained from around the devices. Higher PIFR (e.g. respiratory distress) results in a decrease in the FiO2 delivered through a variable performance device. Rebreathing of carbon dioxide is also possible with low-flow masks at lower oxygen flow rates. Variable performance systems include the nasal cannula, simple mask, partial rebreathing mask, and non-rebreathing mask.

Nasal cannulas are commonly used for stable patients because they are more comfortable, less irritating to skin, and less anxiety-inducing than masks; they also allow the patient to eat, talk, and use incentive spirometry. Nasal cannula can provide 24-40% FiO2 with flow-rates up to 6 L/min. The simple mask is commonly used in the immediate postoperative setting for supplemental oxygen. Several small holes on either side of the mask as well as the imperfect seal allow room air to be entrained and exhaled air to escape from the mask. Simple masks can provide 35-50% FiO2 at flow-rates 5-10 L/min.1 Long-term use of masks can lead to skin irritation and pressure sores.The partial rebreather consists of a simple mask with a reservoir bag, and provides 40-70% FiO2 at flow-rates 6-10 L/min.1 The partial rebreather is no longer used at many hospitals because the range of oxygen delivery can be encompassed by the simple mask and the non-rebreather. The non-rebreathing mask is similar to the partial rebreather but includes one-way valves that prevent exhaled air from returning to the reservoir bag. The non-rebreather can deliver 60-80% FiO2 at 10-15 L/min.1

Fixed performance (high-flow) systems: By delivering oxygen at a flow rate greater than PIFR, fixed performance systems make it possible to provide a specified FiO2 throughout the respiratory cycle. The two commonly used devices are the Venturi mask and OxyMaskTM. Venturi masks use the Bernoulli principle to deliver oxygen at high flows through a Venturi valve that has a narrow constriction followed by a wider area with vents that entrain room air. Because of the relative ease of use and consistent oxygen delivery, they are useful for patients with COPD or others with chronic hypoxemia. The Venturi mask is able to deliver an FiO2 of 24-50%.1 Venturi masks will not be tested in this study.

The OxyMaskTM is a relatively new device that uses the Venturi diffuser with a five-pronged open mask design, which allows the patient to talk and may cause less claustrophobia than the more closed masks. OxyMaskTM is able to deliver 25-80% FiO2 at flow rates of 1.5-15 L/min. A closed mask with a perfect seal could theoretically deliver 100% FiO2. For the purposes of this study, a Jackson Rees circuit will be used to deliver oxygen to an anesthesia mask. The Jackson Rees circuit (also called the Mapleson F circuit) is routinely used during transport to deliver oxygen from the oxygen tank to intubated patients. This circuit consists of tubing connected to a manual ventilation bag that can be squeezed to deliver pressurized gas flow to the patient. The bag is equipped with an adjustable pressure limiting valve, which allows the provider to control the pressure delivered by squeezing the bag.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 70 years of age
  • Male and female volunteers
  • ASA physical status I, II and III
  • Capable and willing to provide written informed consent in English

排除标准

  • Acute cardiopulmonary disease, as defined by blood pressure greater than 150/90, HR greater than 120 and room air oxygen saturation less than
  • Allergy to lidocaine or adhesive tape
  • History or physical exam finding of nasal polyps
  • Currently taking oral or parenteral anticoagulant medications (other than aspirin)
  • History of frequent nose bleeds
  • Current symptoms of nasal congestion
  • Physical examination findings of rales or wheezing
  • Facial hair that prevents forming a seal with an anesthesia mask

结局指标

主要结局

Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor

时间窗: The subjects will each participate on one study day and will require 1 hour per subject.

After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).

Oxygen Concentration Measured at the Oropharyngeal Location by Nasal Catheter

时间窗: The subjects will each participate on one study day and will require 1 hour per subject.

After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Kirsch

Professor and Chair

Oregon Health and Science University

研究点 (1)

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