Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Impairment in at least one PICS domain (mobility, cognition, and/or mental health)
研究概览
简要总结
The aim of this study is to characterize patients in the Post-Intensive-Care-Syndrome (PICS) outpatient clinic based on routine data and to evaluate their treatment outcome over the course of their treatment. For this purpose, data sets from approx. 40 patients who were treated in the intensive care unit subsequently evaluated in the PICS outpatient clinic between March 27, 2020, and May 6, 2024, will be analyzed.
详细描述
This is a retrospective comparison of approximately 13 pregnant patients and approximately 27 non-pregnant patients who developed respiratory failure (also known as acute respiratory distress syndrome, or ARDS) due to COVID-19 infection. The analysis is based on routine treatment data from the Post-Intensive Care Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), as well as intensive care treatment data, primarily from the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK). In some cases, additional data were obtained from the Medical Clinic for Nephrology and Internal Intensive Care Medicine (CCM/CVK/CBF), the Medical Clinic specializing in Hepatology and Gastroenterology (CCM/CVK), and the Department of Infectiology, Pulmonology, and Intensive Care Medicine (CCM).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age: 18 years and older
- •Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6,
- •COVID-19 infection in temporal assocoation with the intensive care unit admission.
- •Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.
- •Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay.
排除标准
- •Gender: Male
- •Diagnosis: Non-COVID or no respiratory failure
结局指标
主要结局
Impairment in at least one PICS domain (mobility, cognition, and/or mental health)
时间窗: 27.03.2020-06.05.2024
Impairment in at least one PICS domain (mobility, cognition, and/or mental health) after discharge from the ICU, assessed at the time of presentation to the PICS outpatient clinic. The planned PICS outpatient presentation takes place 3 and 6 months (ranging from 1 month to 3 years) after the initial ICU stay.
次要结局
- Catecholamine therapy(27.03.2020-06.05.2024)
- Extracorporeal Membrane Oxygenation treatment(27.03.2020-06.05.2024)
- Need for ventilation during ICU treatment(27.03.2020-06.05.2024)
- Duration of ventilation during ICU treatment(27.03.2020-06.05.2024)
- Oxygenation index(27.03.2020-06.05.2024)
- Severity of illness(27.03.2020-06.05.2024)
- Incidence of delirium(27.03.2020-06.05.2024)
- Duration of delirium(27.03.2020-06.05.2024)
- Sedation Medications(27.03.2020-06.05.2024)
- Sedation dosage(27.03.2020-06.05.2024)
- Duration of sedation(27.03.2020-06.05.2024)
- Depth of sedation(27.03.2020-06.05.2024)
- Continuous muscle relaxation(27.03.2020-06.05.2024)
- Vaccination status(27.03.2020-06.05.2024)
- COVID-19-specific immunotherapy(27.03.2020-06.05.2024)
- Type of Anti-infective therapy(27.03.2020-06.05.2024)
- Duration of Anti-infective therapy(27.03.2020-06.05.2024)
- Week of pregnancy(27.03.2020-06.05.2024)
- Need for a cesarean section(27.03.2020-06.05.2024)
- Organ complications(27.03.2020-06.05.2024)
- Nutrition(27.03.2020-06.05.2024)
- Dialysis 1(27.03.2020-06.05.2024)
- Dialysis 2(27.03.2020-06.05.2024)
- Intensive care unit mortality(27.03.2020-06.05.2024)
- Hospital mortality(27.03.2020-06.05.2024)
- 90-day mortality(27.03.2020-06.05.2024)
- 180-day mortality(27.03.2020-06.05.2024)
- Intensive care unit length of stay(27.03.2020-06.05.2024)
- Duration of Hospital stay(27.03.2020-06.05.2024)
- Grip strength Test(27.03.2020-06.05.2024)
- Mobility(27.03.2020-06.05.2024)
- Cognition 1(27.03.2020-06.05.2024)
- Cognition 2(27.03.2020-06.05.2024)
- Mental health(27.03.2020-06.05.2024)
- PBQ Parent-Child Relationship Questionnaire(27.03.2020-06.05.2024)
- Edinburgh Postpartum Depression Questionnaire (EPDS)(27.03.2020-06.05.2024)
- Health-related quality of life(27.03.2020-06.05.2024)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin
Charite University, Berlin, Germany