A Prospective Observational Cohort Study of Awake Prone Position Ventilation Strategy in Patients With Acute Respiratory Failure

Study Overview
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Brief Summary
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Awake prone positioning has been used widely for patients with COVID-19.Many research results are not uniform on the key issue of whether the prognosis of patients can be improved，and most of the subjects were patients with SARS-CoV-2 infected who are not intubated.The investigators will conduct a prospective observational study on patients with acute respiratory failure induced by various causes to determine whether awake prone position can reduce the need to upgrade to invasive mechanical ventilation and improve the prognosis of patients compared with standard treatment.

Official Title
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A Prospective Observational Cohort Study of Awake Prone Position Ventilation Strategy in Patients With Acute Respiratory Failure

Conditions
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Acute Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Older than 17 years, admitted to the ICU;2.Patients with acute respiratory failure meet the following conditions：①Under the condition of breathing air at rest, PaO2 of subjects is lower than 60mmHg and/or PaCO2 is higher than 50mmHg; ②Under the support of COT and HFNC, PaO2/FiO2 of the subject is less than 250; ③ Under the support of NIV ; Exclusion Criteria: 1.Refusing to cooperate with active treatment; 2.Immediate need for intubation as determined by the treating team.3Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)；4.Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury)；

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Awake prone position Group<br>Patients in awake prone position will be included. | |
| Non awake prone position Group<br>Patients in non awake prone position will be included. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal intubation rate | Percentage of patients in each group whose respiratory support means are upgraded to endotracheal intubation | 28 days | 
| Mortality | Death | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hours of prone position at day | Total hours of prone position at day | 28 days | 
| Total number of prone sessions at day | Total number of prone sessions at day | 28 days | 
| Total days of prone positioning therapy | Total days of prone positioning therapy | 28 days | 
| Non-invasive ventilation days | Number of days not receiving non-invasive mechanical ventilation | 28 days | 
| Change in the ROX-index 1-hour after first prone session | The change in the Ratio of SpO2/FiO2 to respiratory rate (ROX-index) | 1 hour | 
| Total length of stay in ICU and hospital | Total length of stay in ICU and hospital | 28 days |