Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Apnea hypopnea index (AHI)
研究概览
简要总结
A recent development is same-day discharge in bariatric surgery, this seems to be safe if proper discharge criteria are used. However, yet there is no guideline for these discharge criteria, including for patients with (potential) Obstructive Sleep Apnea (OSA). To establish proper discharge criteria concerning OSA more information about (changes in) OSA during the first days after bariatric surgery is required.
The aim of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA.
Methods: Patients (n=60) will undergo a Home Sleep Apnea test , pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture.
详细描述
Rationale:
Bariatric surgery is a highly effective and sustainable treatment against obesity. Recently there has been a trend towards Same-Day Discharge (SDD) bariatric surgery. SDD bariatric surgery has proven to be safe, when proper discharge criteria are used. However, there is no consensus or guideline for discharge criteria for SDD bariatric surgery. In particular, discharge criteria for patients with obstructive sleep apnea (OSA) diverge between hospitals. In some, but not all hospitals, having (untreated) OSA is a contra-indication for SDD bariatric surgery.
In Rijnstate hospital, bariatric patients are not routinely tested for OSA preoperatively, meaning that they potentially have undiagnosed OSA. Having potentially undiagnosed OSA, is not a contra-indication for SDD bariatric surgery in Rijnstate hospital. Hospitals could be hesitant for SDD bariatric surgery in patients with OSA, because it is known that the apnea hypopnea index (AHI) increases postoperatively. In a population without obesity, the highest postoperative AHI was found during the third postoperative night. During this third postoperative night, patients with a normal postoperative course will already sleep at home, both after inpatient and SDD bariatric surgery. This raises the question whether having (untreated) OSA should be a contra-indication for SDD bariatric surgery. However, it is unknown if the same postoperative changes in AHI and sleep architecture occur in patients undergoing bariatric surgery. Objective: The primary objective of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA. The secondary objective of this study is to compare postoperative AHI changes between patients with a pre-operative AHI of 0-14 or ≥15. The tertiary objective of this study is to describe and compare pre- and postoperative sleep architecture.
Study design:
This is a prospective observational study. AHI and sleep architecture will be assessed and compared before and after Same-Day discharge (SDD) bariatric surgery during the first and third postoperative night with Home Sleep Apnea Tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 (Roux and y gastric bypass or sleeve gastrectomy)
- •Eligible for same-day discharge
- •In possession and able to use a smartphone
排除标准
- •Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
- •Not eligible for same-day discharge
- •Diagnosed OSA with treatment (CPAP, oral appliances)
- •Professional drivers
- •Use of alpha blockers
- •Unable to speak or read the Dutch language
- •Not in possession or not able to use a smartphone
结局指标
主要结局
Apnea hypopnea index (AHI)
时间窗: Measurements will take place 7 days before and 1 and 3 days after surgery
The AHI will be measured by the Watchpat One and compared between the different timepoints.
次要结局
- Oxygen Desaturation Index (ODI)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- The AHI during rapid eye movement (sleep)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Percentage of time with a saturation <90%(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Total sleep time (minutes)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Percentage of total sleep in REM sleep(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Time in REM sleep (minutes)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Respiratory disturbance index (RDI),(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Time of a saturation <90%(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Mean saturation during desaturations(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Number of desaturations(10 days)
- Percentage of total sleep in deep sleep(Measurements will take place 7 days before and 1 and 3 days after surgery)
- The time in light sleep (minutes)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Mean saturation(Measurements will take place 7 days before and 1 and 3 days after surgery)
- The awake time (minutes)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- The time in deep sleep (minutes)(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Percentage of total sleep in light sleep(Measurements will take place 7 days before and 1 and 3 days after surgery)
- Percentage of awake time(Measurements will take place 7 days before and 1 and 3 days after surgery)