Awaken Prone Positioning Ventinlation in COVID-19 Patients

Study Overview
=================
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.

Official Title
-----------------
Comparison the Prescription of Duration of Awaken Prone Positioning Ventilation Duration in COVID-19 Patients: a Randomised Controlled Study

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Procedure: Awaken prone positioning ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APP group<br>Directive APP for a target of 12 hours per day or more | Procedure: Awaken prone positioning ventilation<br>* patients were mandated to keep a prone position for at least 12 hours.<br>|
| No Intervention: Control group<br>No intervention on APP | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day intubation rate | whether the patients' were intubated | follow-up till 28-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APP duration/days | hours of APP per day | follow-up till APP ended, daily duration of APP also recoreded, up to 7 days | 
| Application of HFNC NIV vasopressor CRRT ECMO sedation, or complication | Whether to apply these treatments，any complications occur,days free from respiratory support and days free from invasive mechanical ventilation at 28 day | follow-up till 28-day | 
| mortality (ICU hospital) length of ICU (hospital) stay | mortality AND mortality and length of stay at 28 day | follow-up during the ICU/hospital stay, up to 28 days |