Nasal Continuous Positive Airway Pressure and Airway Patency in Obese Patient
Comparison of Upper Airway Patency Using Continuous Positive Airway Pressure Ventilation Via a Nasal Mask With a Face Mask During Induction of Anesthesia on Obese Patients
研究概览
详细说明
Upper airway obstruction (UAO) is an unpredictable and frequently occurring complication during induction of general anesthesia. Since obese patients are more vulnerable to develop airway obstruction either during sleep1 or under anesthesia, and the segment of obese individuals in the entire population keep growing, difficult airway management under anesthesia becomes even more challenging than ever. The most serious event related to difficult airway management under anesthesia is "cannot intubate, cannot ventilate".
The mechanism of UAO during anesthesia has not been well understood. Obese patients are a high-risk group for perioperative airway catastrophe and prone to develop progressively narrower pharyngeal airways due to an increase of soft tissue volume surrounding the pharyngeal airway. The mechanism of UAO during anesthesia shares many similarities with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway patent with near 100% success in patients with OSA. Obesity is a major risk factors for obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia. Therefore, the investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients under anesthesia. The investigators propose to test this hypothesis and determine the efficacy of nCPAP on maintaining airway patency in obese patients who require general anesthesia.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Body Mass Index:30 to 50 kg/ m2, Age: 18-65 years old ASA physical status classification: I-III Requiring general anesthesia for elective surgery
Exclusion Criteria:
- Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class IV or greater.
- Abnormal vital signs on the day of admission for surgery [heart rate (HR, >100 bpm or <40 bpm), blood pressure (BP, >180/100 mmHg or <90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) <96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
- Having claustrophobia and not able to tolerate the mask.
- Any person with an anticipated difficult airway or those with a history of difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake.
- Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.
- The subject has been in bed for more than 24 hours.
- Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
- Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.
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学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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FmCPAP
CPAP ventilation administered via face mask
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CPAP and ventilation administered via nasal mask
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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expired tidal volume
大体时间：3 minutes
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This group of the subjects will start with nasal mask or face mask CPAP ventilation.
The anesthesia care team does whatever they routinely do, including adjusting the patient's position (as to reverse Trendelenburg position), pre-oxygenation, pre-medication, as usual with intravenous anesthetics and analgesics.
When the patient is apneic, CPAP ventilation will be initiated with pressure support mode at PIP 25 cmH2O, ventilation rate 10 BPM, PEEP 10 cmH2O and slope 1 second for 1 min.
If ventilation is effective in one of the first three breaths, the ventilation will continue for 1 min.
If effective ventilation cannot be produced in any of the first three breaths, the study will be terminated and routine care will be provided.
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3 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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expired tidal volume/Area under the Curve of the pressure trace
大体时间：3 minutes
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The area under the airway pressure curve (AUC) defined as the area from the baseline pressure to the peak pressure during inspiration was calculated for evaluating pressure applied during inspiration.
The AUC is a reflection of the change in mean airway pressure.
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3 minutes
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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