Incidence of Obstructive Sleep Apnea in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,577
- 试验地点
- 1
- 主要终点
- Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing
研究概览
简要总结
Obstructive sleep apnea is a condition characterized by obstruction of the upper airways and episodes of apnea and hypopnea during sleep. It is associated with significant adverse health effects. The incidence of obstructive sleep apnea in the general female population is approximately 2% but the incidence of obstructive sleep apnea in pregnancy is unknown. There is some evidence that pregnancy precipitates or at least exacerbates this condition and that there may be a relationship between intrauterine fetal growth retardation and maternal preeclampsia. In addition, there are several anesthetic implications that are concern for the patient with obstructive sleep apnea. These include: exquisite sensitivity to all central nervous system depressant drugs and the potential for upper airway obstruction or apnea with even minimal drug doses; difficult mask ventilation; difficult intubation; arterial hypoxemia; arterial hypercarbia; polycythemia; hypertension; pulmonary hypertension and cardiac failure. All of these conditions pose significant anesthetic risk for the patient, and this risk may be increased further by pregnancy.
详细描述
All patients presenting to the Prentice Women's Hospital's (PWH) Labor and Delivery Unit for spontaneous labor, induction of labor and scheduled cesarean delivery are routinely interviewed by a member of the anesthesia team to obtain a detailed history and physical examination and to discuss labor analgesia options. Immediately following this usual and customary preanesthetic evaluation the member of the anesthesia team performing the preanesthetic consultation (anesthesiology attending, resident physician, or nurse) used a standard verbal consent script to obtain verbal consent from the subject for study participation. Study participants were asked to complete a written validated survey, the Berlin Questionnaire, evaluating self-reported snoring and daytime sleepiness as well as basic demographic data (age, height, current weight and pregnancy weight gain). Survey completion time was 1 to 2 minutes.
The survey was available in English and Spanish. It did not contain any subject personal health information. The survey sheet remained in the labor and delivery room with the subject's usual anesthesia medical record paperwork until the patient was discharged from the unit. At the time of discharge, the infant's birthweight and APGAR scores were recorded on the survey and the survey collected.
All female patients, ages 18 - 45, presenting to the PWH Operating Room for elective gynecologic surgery, and all female patients, ages 18 - 45, presenting to the Northwestern Memorial Hospital (NMH) Ambulatory Surgery Center were interviewed by a member of the anesthesia team to obtain a routine preoperative history and physical examination and to discuss the anesthesia options. Immediately following this usual and customary preanesthetic evaluation the member of the anesthesia team performing the preanesthetic consultation (anesthesiology attending, resident physician, or certified registered nurse anesthetist) used a standard verbal consent script to obtain verbal consent from the subject for study participation. Study participants were asked to complete a written validated survey, the Berlin Questionnaire, evaluating self-reported snoring and daytime sleepiness as well as basic demographic data (age, height, and weight). The survey was available in English and Spanish. Survey completion time was 1-2 minutes. The survey did not contain any patient identifying information and was collected after completion.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant Females
- •18 years of age and older
- •scheduled induction of labor
- •spontaneously laboring
- •scheduled cesarean delivery
- •Nonpregnant Females
- •18 years of age or older
- •presenting to the PWH OR for gynecologic surgery
- •presenting to the NMH Ambulatory Surgery Center for ambulatory surgery
排除标准
- •patient refusal
- •patient age > 45 years old
- •inability to understand the English language
- •patient presenting for an emergency procedure
结局指标
主要结局
Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing
时间窗: 1-2 minutes
The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.
次要结局
- Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires(1-2minutes)
研究者
Cynthia Wong
Professor of Anesthesiology
Northwestern University