Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Pontificia Universidad Catolica de Chile
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Therapeutic failure
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Delirium(At 28 days)
- Respiratory superinfection(At 28 days)
- Caloric intake(At 28 days)
- Proteic intake(At 28 days)