Randomized Nasal High Flow Therapy Versus Oxygen Supplementation in Postoperative Care of Obstructive Sleep Apnea Patients With Continuous Positive Airway Pressure Non-Compliance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The 4% change oxygen-desaturation index (4% ODI) determined by pulse oximetry
研究概览
简要总结
The study aims to compare the efficacy of Nasal High Flow Therapy (NHF) with low-flow oxygen supplementation in improving postoperative intermittent desaturations. If so, this mode of therapy would provide a cost effective, relatively easy to implement, and better tolerated treatment to Continuous Positive Airway Pressure (CPAP) for oxygen stabilization.
详细描述
Patients identified preoperatively with previously diagnosed obstructive sleep apnea (intermittent collapse of upper airway while asleep) who refuse Continuous Positive Airway Pressure use after surgery and are treated with routine postoperative supplemental oxygen alone (1 liters per minute) will have more oscillation of oxygen saturation during the night (measure by overnight oximetry) than those treated with high nasal flow air insufflator (Fisher & Paykel Airvo 2 device) with same amount of oxygen supplement (1 liters per minute).
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
- Single (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
- •Known diagnosis of obstructive sleep apnea by polysomnography (Apnea Hypopnea Index ≥ 5 events per hour) with recommendation of Continuous Positive Airway Pressure use.
- •The patient declines use of Continuous Positive Airway Pressure for the upcoming elective surgery.
- •The patient will require more than 48 hours of hospitalization.
- •Informed consent obtained from patient or approved designate.
排除标准
- •Predetermined need for Continuous Positive Airway Pressure post-operatively by surgical team.
- •Body Mass Index ≥
- •Patient with congestive heart failure and diagnosis of Cheyne- Stokes respiration or central apnea.
- •Patients who are oxygen dependent due to moderate to severe Chronic Obstructive Pulmonary Disease (Available Forced Expiratory Volume at 1 second of < 50% predicted) or advanced interstitial lung disease.
- •Preexisting chronic hypercapnia with known neuromuscular disease with respiratory involvement (e.g. Amyotrophic Lateral Sclerosis, myopathy).
- •Severe anemia necessitating blood transfusion.
- •Presence of tracheostomy.
- •Naso-oral malformation or severe nasal septal defect.
- •Presence of dementia or other diagnosed neurodegenerative disease.
- •Non-English speakers
- •Inability to provide informed consent.
研究组 & 干预措施
Low flow oxygen via nasal cannula
In the low flow oxygen via nasal cannula, patients will be supplemented with 1 liter per minute via nasal cannula. Adjustment of initial setting upon floor arrival: To adjust oxygen 1-4 liters per minute to an arterial oxygen saturation of > 88%. Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.
干预措施: Low flow oxygen via nasal cannula (Device)
Humidified Nasal High Flow Therapy
Adjustment of humidified high flow air therapy: To adjust oxygen 1-4 liters per minute to an arterial oxygen saturation of > 88%. To adjust air flow to patient comfort (20-35 liters per minute). Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.
干预措施: Humidified Nasal High Flow Therapy (Device)
结局指标
主要结局
The 4% change oxygen-desaturation index (4% ODI) determined by pulse oximetry
时间窗: At 48 hours postsurgery
The 4% change oxygen-desaturation index (4% ODI) as determined from the recorded pulse oximetry data during the first postoperative 48 hours.
次要结局
- Incidence rate of postoperative cardio-respiratory complications(At 48 hours postsurgery)