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

P

Pontificia Universidad Catolica de Chile

Status

Completed

Conditions

Respiratory Failure
Ards
Covid19

Treatments

Other: Prone position

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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 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).

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

66 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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