Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

Study Overview
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Brief Summary
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The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.

Detailed Description
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The purpose of this study is to investigate the role of prone positioning in SARS-CoV-2 infected patients that are not intubated. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS. However, few attempts have been made to implement the prone position in patients that spontaneously ventilate with supplemental oxygen. Considering that it is a procedure that does not require additional equipment and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality. The investigators will analyze a cohort of patients with COVID-19 and respiratory failure managed with prone position as indicated by the attending physician and register physiological variables and clinical outcomes (intubation and death).

Official Title
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Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

Conditions
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Covid19, Ards, Respiratory Failure

Intervention / Treatment
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* Other: Prone position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90% Treating physician indicated prone position as instructed by the institutional protocol Patient capable of changing position with minimal help from the personnel Exclusion Criteria: Patient requiring immediate intubation Patient requiring non-invasive mechanical ventilation Respiratory Rate > 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway PaCO2 > 50mmHg Hemodynamic instability (defined by Heart Rate > 120, Systolic Pressure < 90mmHg, Mean Arterial Pressure < 60mmHg or requiring vasopressor support) Obesity with BMI > 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2) Persistent vomiting Facial or thoracic trauma or recent surgery contraindicating the prone position Pregnancy > 20 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prone position<br>Prone position per institutional protocol and as indicated by the treating physician | Other: Prone position<br>* Prone position as indicated by the treating physician as specified in the institutional protocol<br>|
| No prone position<br>The control group will not be in prone position | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic failure | Defined by death or intubation or use of non-invasive ventilation | At 14 days | 
| Mortality | Number of patients that die | At day 28 | 
| Length of hospital stay | Number of days spent by the patients at the hospital | At 28 days | 
| Days requiring high flow nasal oxygen | Number of days the patients require high flow nasal oxygen therapy | At 28 days | 
| Days requiring supplemental oxygen | Number of days the patients require supplementary oxygen | At 28 days | 
| Displacement of invasive devices during position changes | Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes | At 28 days | 
| Occurrence of pressure ulcers on the anterior surface of the body | Number of patients that develope pressure ulcers on the anterior surface of the body | At 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory superinfection | Certified by a respiratory tract sample and culture | At 28 days | 
| Delirium | Defined by the Confusion Assessment Method (CAM) | At 28 days | 
| Caloric intake | Daily number of ingested calories (in kilocalories) by the patients is recorded | At 28 days | 
| Proteic intake | Daily number of ingested proteins (in grams) by the patients is recorded | At 28 days |