Hospital Clinico Red de Salud UC - Christus
Santiago, Santiago Metropolitan, Chile
NCT Number: NCT04641182
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.
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Notify Me18 year and older
All sexes
Observational
Santiago, Santiago Metropolitan, Chile
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prone position as indicated by the treating physician as specified in the institutional protocol
Time frame: At 14 days
Defined by death or intubation or use of non-invasive ventilation
Time frame: At day 28
Number of patients that die
Time frame: At 28 days
Number of days spent by the patients at the hospital
Time frame: At 28 days
Number of days the patients require high flow nasal oxygen therapy
Time frame: At 28 days
Number of days the patients require supplementary oxygen
Time frame: At 28 days
Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes
Time frame: At 28 days
Number of patients that develope pressure ulcers on the anterior surface of the body
Time frame: At 28 days
Certified by a respiratory tract sample and culture
Time frame: At 28 days
Defined by the Confusion Assessment Method (CAM)
Time frame: At 28 days
Daily number of ingested calories (in kilocalories) by the patients is recorded
Time frame: At 28 days
Daily number of ingested proteins (in grams) by the patients is recorded
Time frame: At 28 days
Using a scale from 1 to 10 (from 1 no dyspnea to 10 maximum dyspnea)
Time frame: At 28 days
Using a scale from 1 to 4 (1 is very comfortable and 4 is very uncomfortable)
Time frame: At 28 days
Using PAFI (PAFI: Index calculated by Pressure of Arterial Oxygen / Inspired Fraction of Oxygen)
Time frame: At 28 days
Using SAFI (SAFI: Index calculated by Oxygen Saturation by Pulse Oximetry / Inspired Fraction of Oxygen)
Pontificia Universidad Catolica de Chile
Other
Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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