Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

Covid19 Clinical Trial

Official title:

Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641182
• Other study ID #: 0001
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: September 16, 2020

Study information

• Verified date: November 2020
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 16, 2020
• Est. primary completion date: August 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ards
• Covid19
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Prone position
Prone position as indicated by the treating physician as specified in the institutional protocol

Locations

Country	Name	City	State
Chile	Hospital Clinico Red de Salud UC - Christus	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dyspnea	Using a scale from 1 to 10 (from 1 no dyspnea to 10 maximum dyspnea)	At 28 days
Other	Comfort with the position	Using a scale from 1 to 4 (1 is very comfortable and 4 is very uncomfortable)	At 28 days
Other	Oxygen saturation	Using PAFI (PAFI: Index calculated by Pressure of Arterial Oxygen / Inspired Fraction of Oxygen)	At 28 days
Other	Oxygen saturation	Using SAFI (SAFI: Index calculated by Oxygen Saturation by Pulse Oximetry / Inspired Fraction of Oxygen)	At 28 days
Primary	Therapeutic failure	Defined by death or intubation or use of non-invasive ventilation	At 14 days
Primary	Mortality	Number of patients that die	At day 28
Primary	Length of hospital stay	Number of days spent by the patients at the hospital	At 28 days
Primary	Days requiring high flow nasal oxygen	Number of days the patients require high flow nasal oxygen therapy	At 28 days
Primary	Days requiring supplemental oxygen	Number of days the patients require supplementary oxygen	At 28 days
Primary	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	At 28 days
Primary	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	At 28 days
Secondary	Respiratory superinfection	Certified by a respiratory tract sample and culture	At 28 days
Secondary	Delirium	Defined by the Confusion Assessment Method (CAM)	At 28 days
Secondary	Caloric intake	Daily number of ingested calories (in kilocalories) by the patients is recorded	At 28 days
Secondary	Proteic intake	Daily number of ingested proteins (in grams) by the patients is recorded	At 28 days