Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COVID-19, Acute Respiratory Distress Syndrome Due to COVID-19, Pregnancy Related. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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).
Primary outcome measures
- Impairment in at least one PICS domain (mobility, cognition, and/or mental health) [Time frame: 27.03.2020-06.05.2024]
Secondary outcome measures (12)
- Catecholamine therapy [Time frame: 27.03.2020-06.05.2024]
- Extracorporeal Membrane Oxygenation treatment [Time frame: 27.03.2020-06.05.2024]
- Need for ventilation during ICU treatment [Time frame: 27.03.2020-06.05.2024]
- Duration of ventilation during ICU treatment [Time frame: 27.03.2020-06.05.2024]
- Oxygenation index [Time frame: 27.03.2020-06.05.2024]
- Severity of illness [Time frame: 27.03.2020-06.05.2024]
- Incidence of delirium [Time frame: 27.03.2020-06.05.2024]
- Duration of delirium [Time frame: 27.03.2020-06.05.2024]
- Sedation Medications [Time frame: 27.03.2020-06.05.2024]
- Sedation dosage [Time frame: 27.03.2020-06.05.2024]
- Duration of sedation [Time frame: 27.03.2020-06.05.2024]
- Depth of sedation [Time frame: 27.03.2020-06.05.2024]
Eligibility criteria
Inclusion criteria
- 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, 2024.
- 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.
Exclusion criteria
- Gender: Male
- Diagnosis: Non-COVID or no respiratory failure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitäts — Berlin
Identifiers
NCT: NCT07051967 · CovPreg