Preoxygenation With Optiflow™, a High Flow Nasal Cannula (HFNC), is Superior to Preoxygenation With Facemask in Morbidly Obese Patients Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to desaturation
研究概览
简要总结
Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. This study will examine whether Optiflow can do this, and compare the pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.
详细描述
The use of high flow nasal cannula (HFNC) originated in neonatal care, and has become widespread in its application for patients that are high risk for hypoxemia, both in critical care and emergency settings. Therefore, high flow nasal oxygenation continues to be studied in airway management for preoxygenation, as well as maintenance of oxygenation in airway procedures. Optiflow™, a humidified high flow nasal cannula, has already been shown to be useful in preventing desaturation during intubation in ICU patients versus the non-rebreathing mask, in addition to, prolonging safe apnea time in patients with potential difficult airways. Additionally, preoxygenation with HFNC prior to intubation of patients in hypoxemic respiratory failure has also been shown to decrease desaturation during apnea compared to preoxygenation with traditional bag valve mask. The morbidly obese patient presents a separate group of challenges to the anesthesiologist in regards to mask ventilation and intubation. Obesity (along with other factors) has been shown to contribute to difficulty with mask ventilation. Obese patients have altered respiratory physiology, including decreased functional residual capacity, increased oxygen consumption and lower tidal volumes, as compared to the non-obese patient. These factors contribute to obese patients potentially having a shorter apnea time before desaturating during induction of general anesthesia, as compared to the non-obese patient. Weight is inversely correlated with safe apnea time. Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. If demonstrated to be efficacious as a method for preoxygenation and prolongation of apneic time, this could provide a safer environment for intubation in this particular patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
- •BMI > 40 kg/m2
- •American Society of Anesthesiology (ASA) Physical Status II-III
排除标准
- •Chronic hypoxemia (SpO2 <94% on room air or on home oxygen)
- •Acute respiratory failure
- •Coronary artery disease and/or congestive heart failure
- •Moderate-Severe pulmonary hypertension and/or RV dysfunction
- •Full stomach (recently eaten)
- •Pregnancy
- •Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)
- •Respiratory tract pathology
- •Facial Abnormality
- •American Society of Anesthesiology (ASA) Physical Status IV-V
研究组 & 干预措施
Preoxygenation with face mask
Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
干预措施: facemask (Device)
Preoxygenation with face mask
Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
干预措施: Rocuronium (Drug)
Preoxygenation with face mask
Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
干预措施: Propofol (Drug)
Preoxygenation with face mask
Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
干预措施: Fentanyl (Drug)
Preoxygenation with face mask
Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
干预措施: Midazolam (Drug)
Preoxygenation with face mask
Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
干预措施: C-MAC Premium Video Intubation Platform-KARL STORZ (Device)
Preoxygenation via hi flow nasal cannula
The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
干预措施: Optiflow F&P 850™ System (Device)
Preoxygenation via hi flow nasal cannula
The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
干预措施: Rocuronium (Drug)
Preoxygenation via hi flow nasal cannula
The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
干预措施: Propofol (Drug)
Preoxygenation via hi flow nasal cannula
The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
干预措施: Fentanyl (Drug)
Preoxygenation via hi flow nasal cannula
The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
干预措施: Midazolam (Drug)
Preoxygenation via hi flow nasal cannula
The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
干预措施: C-MAC Premium Video Intubation Platform-KARL STORZ (Device)
结局指标
主要结局
Time to desaturation
时间窗: up to 10 minutes
Intraoperatively, apneic time will be record from the time of administration of the muscle relaxant. The time until the first desaturation will be recorded. The maximum time of measurement will be 10 minutes.
次要结局
- Time until hypercarbia > 65 mmHg(up to 10 minutes)
- Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring(up to 10 minutes)
研究者
Tracey Straker
Co-principal investigator, Attending Anesthesiologist
Montefiore Medical Center