An observational study in Covid19, Ards and Respiratory Failure, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-23.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 66 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalized COVID-19 adult patients with acute respiratory failure
Exclusion Criteria:
Prone position per institutional protocol and as indicated by the treating physician
Other: Prone position
The control group will not be in prone position
Prone position as indicated by the treating physician as specified in the institutional protocol
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
Respiratory superinfection
Certified by a respiratory tract sample and culture
Time frame: At 28 days
Delirium
Defined by the Confusion Assessment Method (CAM)
Time frame: At 28 days
Caloric intake
Daily number of ingested calories (in kilocalories) by the patients is recorded
Time frame: At 28 days
Proteic intake
Daily number of ingested proteins (in grams) by the patients is recorded
Time frame: At 28 days
Dyspnea
Using a scale from 1 to 10 (from 1 no dyspnea to 10 maximum dyspnea)
Time frame: At 28 days
Comfort with the position
Using a scale from 1 to 4 (1 is very comfortable and 4 is very uncomfortable)
Time frame: At 28 days
Oxygen saturation
Using PAFI (PAFI: Index calculated by Pressure of Arterial Oxygen / Inspired Fraction of Oxygen)
Time frame: At 28 days
Oxygen saturation
Using SAFI (SAFI: Index calculated by Oxygen Saturation by Pulse Oximetry / Inspired Fraction of Oxygen)
Time frame: At 28 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile