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

Pontificia Universidad Catolica de Chile66 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Covid19 Ards Respiratory Failure

Interventions

Prone positionOTHER

Prone position as indicated by the treating physician as specified in the institutional protocol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinico Red de Salud UC - Christus

Santiago, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

Therapeutic failure

Defined by death or intubation or use of non-invasive ventilation

Time frame: At 14 days

Mortality

Number of patients that die

Time frame: At day 28

Length of hospital stay

Number of days spent by the patients at the hospital

Time frame: At 28 days

Days requiring high flow nasal oxygen

Number of days the patients require high flow nasal oxygen therapy

Time frame: At 28 days

Days requiring supplemental oxygen

Number of days the patients require supplementary oxygen

Time frame: 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

Time frame: 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

Time frame: At 28 days

Secondary Outcomes

Respiratory superinfection

Certified by a respiratory tract sample and culture

Time frame: At 28 days

Data from ClinicalTrials.gov

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