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

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.

Full Title of Study: “Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 16, 2020

Detailed Description

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).

Interventions

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

Arms, Groups and Cohorts

  • Prone position
    • Prone position per institutional protocol and as indicated by the treating physician
  • No prone position
    • The control group will not be in prone position

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pontificia Universidad Catolica de Chile
  • Provider of Information About this Clinical Study
    • Sponsor

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