Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary.
The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy.
Methods:
Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B:
Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
详细描述
Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed.
Objective
The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients
Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy.
Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG.
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
- 否
入选标准
- •Undergo primary bariatric surgery (RYGB or SG)
- •Speak and read the Dutch language
排除标准
- •Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
- •Same-day discharge after bariatric surgery
- •Diagnosed OSA with treatment (CPAP, oral appliances)
- •Professional drivers
- •Use of alpha blockers
- •Unable to speak or read the Dutch language
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: First postoperative night
AHI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms, the higher the AHI the more severe the sleep apnea
次要结局
- Percentage of saturation <85%(First postoperative night)
- Mean saturation(First postoperative night)
- Mean saturation during desaturations,(First postoperative night)
- Percentage of saturation <90%(First postoperative night)
- Percentage of saturation <80%(First postoperative night)
- Time (minutes) of saturation <80%(First postoperative night)
- Percentage of light sleep in total sleep time(First postoperative night)
- The number of nursing interventions(First postoperative night)
- Type of nursing interventions(First postoperative night)
- AHI during Rapid Eye Movement (REM) sleep(First postoperative night)
- Respiratory disturbance index (RDI)(First postoperative night)
- Percentage of saturation <88%(First postoperative night)
- Complication rate(Until 30 days after surgery)
- Number of desaturations(First postoperative night)
- Time (minutes) of saturation <70%(First postoperative night)
- Percentage of Deep sleep in total sleep time(First postoperative night)
- Oxygen Desaturation Index (ODI)(First postoperative night)
- Percentage of saturation <70%(First postoperative night)
- Time (minutes) of saturation <85%(First postoperative night)
- Time (minutes) of saturation <90%(First postoperative night)
- Percentage of REM sleep in total sleep time(First postoperative night)
- Time (minutes) of saturation <88%(First postoperative night)
- Total sleep time (minutes)(First postoperative night)
- Percentage of awake time(First postoperative night)