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NCT05679440
Postural Changes and Severe COVID-19
Conditions: COVID-19
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: Wuhan Union Hospital, China
Location: China
Summary
COVID-19 remains a widespread global epidemic, increasing morbidity, mortality, healthcare resource consumption, and socio-economic burden on patients worldwide.
The onset of COVID-19 ranges from mild, self-limiting respiratory disease to severe progressive pneumonia, mainly acute respiratory distress syndrome (ARDS), with critically ill patients requiring admission to the intensive care unit (ICU).Prone positioning has been shown to improve oxygenation and reduce complications and mortality in patients with severe ARDS.
Prone position increases functional residual volume and chest wall elasticity, reduces dorsal segment edema in both lower lungs, facilitates uniform ventilation distribution, improves V/Q ratio, reduces alveolar shunts, and aids secretion drainage.
In clinical practice, the prone position is mainly used for patients with diffuse bilateral lung lesions.
However, it is less effective in unilateral or predominantly upper lung patients.
Moreover, some patients are unable to tolerate prone ventilation.
Therefore, we construct an individualized approach to postural oxygen therapy by guiding the patient's position based on the pulmonary imaging information.A study on the optimal ventilation position for patients with severe COVID-19 will be conducted at the Department of Respiratory and Critical Care Medicine, Wuhan Union Hospital.
The investigators enrolled adult patients (without endotracheal intubation) diagnosed with severe COVID-19 requiring oxygen therapy from 2023.01.10 to 2024.01.10.
Patients were grouped into control and intervention groups according to current treatment protocol and pulmonary imaging combined with patients' wishes and degree of postural tolerance.
Patients in the intervention group were ventilated in different positions according to pulmonary imaging, including prone, left/right lateral, supine, semi-recumbent, and seated.
In contrast, patients in the control group were ventilated comfortably according to the treatment principles and their wishes.
The primary observation was 28-day mortality.
Secondary observations were oxygenation index (PaO2/FiO2) before and after a position change, endotracheal intubation rate, duration of respiratory support, length of hospital stay, and comfort in position.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsAdmitted with a confirmed diagnosis of COVID-19 severe pneumoniaPatients without endotracheal intubation requiring high flow nasal cannula, non-invasive ventilator, mask, nasal cannula assisted ventilationSigned informed consentExclusion Criteria:Hemodynamic instabilityUnstable spinal fracturesUnstable pelvic or long bone fracturesOpen abdominal woundsLate pregnancyIncreased intracranial pressure due to a lesion in the head and neck that obstructs cerebral venous drainage.
Source: ClinicalTrials.gov (NCT05679440). StuddyBuddy aggregates publicly available trial information.