A Pilot Study of FDA Approved Optiflow™ THRIVE Versus Standard Non-Rebreathers in Patients With Potential High Risk of Airway Obstruction During Total Intravenous Anesthesia (TIVA) While Undergoing Interventional Radiology Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure
研究概览
简要总结
This trial studies how well Optiflow THRIVE works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. The Optiflow THRIVE is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. The Optiflow THRIVE device may improve oxygen delivery and reduce breathing complications.
详细描述
PRIMARY OBJECTIVE:
I. To investigate the performance of Optiflow THRIVE relative to Standard Non-Rebreathers in patients with high risk of difficult airway management undergoing interventional radiology procedures for the planning of future clinical studies.
SECONDARY OBJECTIVE:
I. To describe the episodes of hypoxia (defined by peripheral capillary oxygen saturation [SpO2] less than or equal to 92%) and the episodes of airway support which include: jaw thrust, chin lift or insertion of an airway supporting device, such as oral/nasal airway or supra airway device in order to recover the level of oxygenation above 92% associated with Optiflow THRIVE.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Signed consent for the study
- •Patients with an SpO2 greater than or equal to 95% while breathing room air
- •Patients requiring total intravenous anesthesia (TIVA) but not tracheal intubation during the proposed procedure - PLUS, any of the 2 following criteria: Body mass index (BMI) greater than or equal to 32 kg/m^2, or neck circumference greater than or equal to 43 cm in a male and 41 cm in a female, or has been diagnosed with moderate to severe obstructive sleep apnea (OSA) with/without using a continuous positive airway pressure (CPAP) device
- •Full course head and neck radiotherapy less than or equal to 6 months (the peak onset time of acute facial and airway edema)
排除标准
- •Significant pulmonary disease requiring supplemental oxygen in daily life (severe pulmonary fibrosis, severe chronic obstructive pulmonary disease, etc.)
- •Significant cardiac disease (including history of myocardial infarction [MI] with concurrent evidence of ischemic myocardial damage at the event, cardiomyopathy with impaired left ventricular ejection fraction to less than 50% or uncompensated congestive heart failure)
- •TIVA is contraindicate or having a proposed procedure without TIVA
- •Endotracheal intubation is required
- •American Society of Anesthesiologists (ASA) physical status classification 5
- •Patients who are non-English speaking
- •Emergency procedures
研究组 & 干预措施
Arm I (oxygen via Optiflow THRIVE)
Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.
干预措施: Optiflow THRIVE (Device)
Arm I (oxygen via Optiflow THRIVE)
Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.
干预措施: Questionnaire Administration (Other)
Arm II (oxygen via non-rebreather mask)
Patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure.
干预措施: Questionnaire Administration (Other)
Arm II (oxygen via non-rebreather mask)
Patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure.
干预措施: Oxygen Therapy (Procedure)
Arm I (oxygen via Optiflow THRIVE)
Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.
干预措施: Oxygen Therapy (Procedure)
结局指标
主要结局
Total Length of Desaturation Episodes (ToLDE) Per Patient/Surgical Procedure
时间窗: 60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes
This measure is defined as the total length (in minutes) of all desaturation episodes that a patient experienced during a 60-minute observation window starting from the initiation of the propofol infusion. A desaturation episode is defined as a drop in oxygen saturation (SpO2) to 92% or lower.
次要结局
- Number of Desaturation Episode Events Per Patient/Surgical Procedure(60-minute observation window starting from the initiation of the propofol infusion and continuing for 60 minutes)
- Number of BIS Episodes(60-minute observation window starting from the initiation of the propofol infusion.)
- PACU Observation Time(up to 60 minutes after PACU admission)