An observational study in ARDS Due to Disease Caused by SARS Co-V-2 and Right Ventricular Dysfunction, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational
In coronavirus disease-2019 (COVID-19)-related ARDS (C-ARDS), especially in the severe form, increased shunt rate, impaired ventilation/perfusion ratio (V/Q), hypoxic pulmonary vasoconstriction inhibition, and increased immune microthrombosis may have similar effects on the right ventricle .The cardiopulmonary pathophysiology and outcomes of C-ARDS vary, and this variability requires monitoring to follow the diagnosis and treatment process. This study aimed to increase the treatment success of the prone position in C-ARDS and to provide a prognostic factor for survival by analyzing and monitoring heart-lung interactions. Therefore, we used transesophageal echocardiography (TEE) to evaluate the cardiopulmonary effects of prone position.
This prospective study included 30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (PP) (T0), the first hour of PP (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment. Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) was preferred right ventricular evaluations as primer outcome. Static compliance (C-stat) was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 122 studies on the registry; 14 are open to participants now.
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moderate/severe C-ARDS patients admitted to the Bakırköy Dr Sadi Konuk Training and Research Hospital Anesthesiology and Reanimation Clinic Intensive Care Unit, who received invasive mechanical ventilation support and applied prone position in the first 48 h were included.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 moderate-to-severe C-ARDS patients who were treated with prone position in the first 48 hours of invasive mechanical ventilation support. It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment.
Procedure: before prone position · Procedure: the first hour of prone position · Procedure: the first hour of returning to the supine position
It was evaluated with transesophageal echocardiography
Also known as: t0
It was evaluated with transesophageal echocardiography
Also known as: t1
It was evaluated with transesophageal echocardiography
Also known as: t2
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) change during prone position.
It was preferred right ventricular recovery evaluation.
Time frame: It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment
Static compliance (C-stat) change with prone position
It was examined in the evaluation of the pulmonary effect of prone position as secondary outcome.
Time frame: It was evaluated with transesophageal echocardiography three times: before prone position (T0), the first hour of prone position (T1), and the first hour of returning to the supine position (T0 + 24 hours) (T2) after 23 hours prone position treatment
Plan to share: Yes — Data available from the publication date can start If requested, data will be shared with medical doctors dealing with
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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