Preoperative CPAP Treatment on Perioperative Outcomes in Rheumatic Valvular Heart Disease Patients With OSA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- duration of ICU stay
研究概览
简要总结
The prevalence of OSA (Obstructive sleep apnea，OSA) is 2%-4% in general population and 16%-47% in surgical-heart failure patients. Our previous study found that OSA was associated with the increasing incidence of perioperative adverse events.The continuous positive airway pressure (CPAP), as the standard treatment for OSA, is extensively applied clinically. The previous study reported that postoperative AHI was reduced and SPO2 was increased by CPAP treatment. However, whether CPAP treatment can improve OSA postoperative and related adverse events or not in patients with rheumatic valvular heart diseases (RVHD) were not reported.The purpose of this study is to observe the effective of preoperative CPAP on postoperative sleep parameters and adverse events, such as AHI changes, duration of ICU stay and duration of mechanical ventilation.
详细描述
Between December 1, 2017 and June 30 2019, 200 patients with chronic heart failure caused by rheumatic valvular heart disease waiting for heart valve replacement in Department of Cardiovascular Surgery were screened for obstructive sleep apnea (OSA) by full-night polysomnography (PSG). Of them, 30 OSA patients were enrolled and randomly received CPAP treatment and non-CPAP treatment (15:15).
The CPAP treatment group received both baseline and CPAP treatment. The full-night CPAP treatment was conducted from 21:00 pm to 6:00 am for 7 days preoperatively. The non-CPAP treatment group received baseline treatment.
Preoperative Sleep parameters (AHI, mean and lowest SPO2) and clinical evaluations including NYHA class, electrocardiographic, echocardiographic, arterial blood gas analysis findings, baseline medication, and 6-minute walk test were recorded.
Operation related parameters such as duration of operation, duration of cardiopulmonary bypass and bleeding volume were recorded.
Postoperative adverse events such as duration of ICU stay, postoperative duration of mechanical ventilation, pacemaker use, complicated infection and reintubation are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years.
- •Patients with rheumatic valvular heart disease.
- •Patients combined with obstructive sleep apnea (apnea-hypopnea index >=5/h).
- •Received heart valve replacement surgery.
- •The enrolled patients having received patients' informed consent.
排除标准
- •History of stroke or clinical signs of peripheral or central nervous system disorders.
- •History of Chronic obstructive pulmonary disease or asthma.
- •Enrolment in another clinical study.
结局指标
主要结局
duration of ICU stay
时间窗: 3 days, depends on the patient's recovery
Postoperative duration of ICU stay was compared between CPAP and non-CPAP patients.
apnea-hypopnea index (AHI)
时间窗: 2 weeks,depends on length of hospital stay
The changes of apnea-hypopnea index pre- and post-operative were compared between CPAP and non-CPAP patients.
length of mechanical ventilation
时间窗: 1 day, depends on the patient's recovery
Postoperative length of mechanical ventilation was compared between CPAP and non-CPAP patients.
次要结局
- complicated infection and reintubation(3 days, depends on the patient's recovery)
- mean and lowest SPO2(2 weeks,depends on length of hospital stay)
- pacemaker use(3 days, depends on the patient's recovery)
研究者
Ning Ding
Principal Investigator
Nanjing Medical University