Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Gender: Male

Diagnosis: Non-COVID or no respiratory failure

Trial population

Adult female pregnant and non-pregnant patients who were admitted 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, Charité - Universitaetsmedizin Berlin between March 27, 2020 and May 6, 2024.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: Female pregnant patients with COVID-19 related Acute respiratory distress syndrome
Group B: Female non-pregnant patients with COVID-19 related Acute respiratory distress syndrome

Trial outcomes

Primary outcomes

1

Impairment in at least one PICS domain (mobility, cognition, and/or mental health)

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.

Time frame
27.03.2020-06.05.2024

Secondary outcomes

1

Catecholamine therapy

Catecholamine therapy during intensive care unit (ICU) treatment is measured in doses and duration.

Time frame
27.03.2020-06.05.2024
2

Extracorporeal Membrane Oxygenation treatment

Extracorporeal Membrane Oxygenation treatment in the ICU Yes or No

Time frame
27.03.2020-06.05.2024
3

Need for ventilation during ICU treatment

Need for ventilation during ICU treatment and, if so, ventilation route (non-invasive and invasive, endotracheal tube and tracheostomy tube) and duration of ventilation

Time frame
27.03.2020-06.05.2024
4

Duration of ventilation during ICU treatment

Duration of ventilation during ICU treatment is measured in hours

Time frame
27.03.2020-06.05.2024

Other outcomes

Sponsors and contacts

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