COVID-19
Conditions
Brief summary
Awaken prone positioning (APP) ventilation has been widely accepted as a standard regimen in the management of COVID-19 patients. Physiological studies have proved ventilation/perfusion improvement during APP in COVID-19, which was associated improved oxygenation. However, the optimal duration for APP was not yet demonstrated. In this study, we aimed at the prolonged APP to see whether this could improve patients outcomes.
Interventions
PROCEDUREAwaken prone positioning ventilation
patients were mandated to keep a prone position for at least 12 hours.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Aged \> 18-yr to 85-yr * Severe COVID-19 pneumonia (with typical radiographic alternations) and non-intubated patients. * SpO2 \<= 93% with ambient air at rest. * PaO2/FiO2 \<= 300 mmHg
Exclusion criteria
* Definite intolerance to APP (e.g. pregnancy, extremity deformity, recent fracture, open thoracic or abdominal surgery, pace-maker implant in recent 48-hr, spine stability, pelvis or facial fractures, predicted difficult airway) * morbidity obesity, BMI \> 40 * consciousness disorder (GCS \< 13), delirium dementia * hemodynamic instability (with norepinephrine \>20 ug/min ) * NYHA Grade III or IV * Severe hemoptysis * long term home oxygenation of CPAP * Refuse invasive mechanical ventilation (DNI DNR)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day intubation rate | follow-up till 28-day | whether the patients' were intubated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| APP duration/days | follow-up till APP ended, daily duration of APP also recoreded, up to 7 days | hours of APP per day |
| Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication | follow-up till 28-day | Whether to apply these treatments，any complications occur,days free from respiratory support and days free from invasive mechanical ventilation at 28 day |
| mortality (ICU hospital) length of ICU (hospital) stay | follow-up during the ICU/hospital stay, up to 28 days | mortality AND mortality and length of stay at 28 day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of interest | 28 post-randomisation | All adverse events of interest that occur in both randomised arms will be reported up to day 28 post-randomisation, including the following: * Nausea, * Unintentional removal of intravenous access, * Pressure ulcer, * Unexpected respiratory cardiac arrest Nausea, Unintentional removal of intravenous access, Pressure ulcer，Unexpected respiratory cardiac arrest |
Countries
China
Outcome results
None listed