Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients in an Urban Low-Resource Setting (LUSIP) - an Observational Study in Sierra Leone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Proportion of parturients with pulmonary complications
研究概览
简要总结
This study aims at describing the frequency, timing and type of pulmonary complications detected with lung ultrasound in critically-ill parturients in admitted to a high-dependency unit in Freetown, Sierra Leone.
详细描述
Rationale: The three big 'killers' in parturients, peripartum hemorrhage, sepsis and pre-eclampsia all predispose to pulmonary complications. These complications affect management before, during and after the primary obstetric problem has been solved. A timely diagnosis and thorough follow-up of pulmonary complications may benefit parturients. Lung ultrasound (LUS) is a point-of-care imaging bedside tool increasingly used in the critical care setting that may prove useful in parturients.
Objective: To describe frequency, timing and type of pulmonary complications detected with LUS in critically ill parturients in a high-dependency unit (HDU), and to determine the association with outcome.
Hypotheses: Pulmonary complications detected by LUS are frequent in parturients admitted to a HDU in a resource-limited setting, and are associated with hospital mortality.
Study design: A prospective observational study. Study population: Critically ill parturients admitted to the HDU of the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.
Sample size: No formal sample size calculation is performed. Based on current rates of admissions to the HDU of the PCMH the investigators expect to perform LUS in at least 125 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Admitted to the HDU of the PCMH during the study period
- •Verbal informed consent of the patient or his/her formal representative
排除标准
- •Lung ultrasound not feasible, e.g., due to electricity breakdown, or absence of the trained sonographer.
结局指标
主要结局
Proportion of parturients with pulmonary complications
时间窗: From admission to 48 hours later
proportion of parturients with pulmonary complications detected by LUS during stay in the HDU.
次要结局
- Description of lung ultrasound findings(From admission to 48 hours later)
- Relative risk of death in patients with a pulmonary complication(On the day of HDU discharge or death, whichever came first, assessed up to 12 weeks after enrollment)
- Description of diagnoses made with lung ultrasound(From admission to 48 hours later)
研究者
Prof. Dr. Marcus J. Schultz
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)