Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- SpO2 < 90%
研究概览
简要总结
The primary aim of the study is to evaluate the effect of the method of delivery (vaginal delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean section compared with vaginal delivery, expressed as either the duration of SpO2 below 90% or the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations by at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a lower mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery group.
The secondary aim of the study is to investigate how the upper body position during sleep (45 degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum night.
The investigators hypothesize that an upper body elevation to 45 degrees decreases the incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the ODI , compared with a non-elevated body position within each delivery group (vaginal delivery or cesarean section).
The third aim of the study is to identify independent predictors of nocturnal desaturation in postpartum women. To that end, the investigators will administer questionnaires and collect demographic and clinical data according to various obstructive sleep apnea screening scores, including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will also ask the patient to rate the pain during the study night on a verbal numerical rating scale.
详细描述
Sleep-disordered breathing is common in pregnancy, persisting into the early postpartum period. Postpartum airway obstruction is a main cause of anesthesia-related maternal death in North America. Upper airway edema following labor and delivery may impair pharyngeal anatomy, which can lead to increased vulnerability of the airway collapse during sleep.
This study evaluates whether the kind of delivery (vaginal birth versus cesarean section) has an effect on nocturnal desaturation in the first night after delivery. Furthermore, the investigators examine if the upper body position during sleep has an effect on the occurrence of oxygen desaturation.
In addition, the investigators evaluate if preexisting conditions, as indicated by a high P-SAP or STOP-Bang-score increase the likelihood of nocturnal desaturation.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum mothers within 24 hours of delivery
- •Age over 18 years.
- •Admitted to the Massachusetts General Hospital OB service for the delivery.
- •Interventions will be randomly assigned to the patients enrolled in this study
排除标准
- •1 Age under 18 years
结局指标
主要结局
SpO2 < 90%
时间窗: 48 hours after delivery
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
次要结局
- Oxygen Desaturation Index > 3(48 hours after delivery)
- P-SAP Score(48 hours after delivery)
- Pain-score on a Verbal Numerical Rating Scale(48 hours after delivery)
- Minimal & Mean SpO2(48 hours after delivery)
- STOP-BANG Score(48 hours after delivery)
- Average Pulse Rate(48 Hours after delivery)
研究者
Matthias Eikermann, MD PhD
Director of Research, Critical Care Division, Associate Professor of Anesthesia, Harvard Medical School
Massachusetts General Hospital