Clinical trial NCT04641182: Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
Official title: Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Ards
Respiratory Failure
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized COVID-19 adult patients with acute respiratory failure

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).

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

Primary outcomes:
measure: Therapeutic failure
timeFrame: At 14 days
measure: Mortality
timeFrame: At day 28
measure: Length of hospital stay
timeFrame: At 28 days
measure: Days requiring high flow nasal oxygen
timeFrame: At 28 days
measure: Days requiring supplemental oxygen
timeFrame: At 28 days
measure: Displacement of invasive devices during position changes
timeFrame: At 28 days
measure: Occurrence of pressure ulcers on the anterior surface of the body
timeFrame: At 28 days
Secondary outcomes:
measure: Respiratory superinfection
timeFrame: At 28 days
measure: Delirium
timeFrame: At 28 days
measure: Caloric intake
timeFrame: At 28 days
measure: Proteic intake
timeFrame: At 28 days
Other outcomes:
measure: Dyspnea
timeFrame: At 28 days
measure: Comfort with the position
timeFrame: At 28 days
measure: Oxygen saturation
timeFrame: At 28 days
measure: Oxygen saturation
timeFrame: At 28 days
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Red de Salud UC - Christus
state: Region Metropolitana
Study officials:
References: