Ards, Covid19, Respiratory Failure
Conditions
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).
Interventions
OTHERProne position
Prone position as indicated by the treating physician as specified in the institutional protocol
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of pressure ulcers on the anterior surface of the body | At 28 days | Number of patients that develope pressure ulcers on the anterior surface of the body |
| Therapeutic failure | At 14 days | Defined by death or intubation or use of non-invasive ventilation |
| Mortality | At day 28 | Number of patients that die |
| Length of hospital stay | At 28 days | Number of days spent by the patients at the hospital |
| Days requiring high flow nasal oxygen | At 28 days | Number of days the patients require high flow nasal oxygen therapy |
| Days requiring supplemental oxygen | At 28 days | Number of days the patients require supplementary oxygen |
| Displacement of invasive devices during position changes | At 28 days | Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory superinfection | At 28 days | Certified by a respiratory tract sample and culture |
| Delirium | At 28 days | Defined by the Confusion Assessment Method (CAM) |
| Caloric intake | At 28 days | Daily number of ingested calories (in kilocalories) by the patients is recorded |
| Proteic intake | At 28 days | Daily number of ingested proteins (in grams) by the patients is recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comfort with the position | At 28 days | Using a scale from 1 to 4 (1 is very comfortable and 4 is very uncomfortable) |
| Oxygen saturation | At 28 days | Using PAFI (PAFI: Index calculated by Pressure of Arterial Oxygen / Inspired Fraction of Oxygen) |
| Dyspnea | At 28 days | Using a scale from 1 to 10 (from 1 no dyspnea to 10 maximum dyspnea) |
Countries
Chile
Outcome results
None listed