Postural Changes and Severe COVID-19

NCT05679440 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Postural interventions based on pulmonary imaging

The main difference between the intervention group and the control group was the position during oxygen therapy. Patients in the intervention group were placed in the appropriate position for oxygen therapy according to pulmonary imaging, while patients in the control group were placed in the appropriate position for oxygen therapy according to conventional treatment principles and the patient's wishes.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Xiaorong Wang, Ph.D., M.D. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-01-10
Completion
2024-01-10

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05679440 on ClinicalTrials.gov