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

Completed

• Conditions: Covid19; Ards; Respiratory Failure
• Interventions: Other: Prone position

• Registration Number: NCT04641182
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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).

Study Timeline

• Study Start: 2020-07-06
• Primary Completion: 2020-08-16
• Study First Submitted: 2020-09-12
• Study Completion: 2020-09-16
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-20
• Last Update Submitted: 2020-11-20
• Study First Posted: 2020-11-23
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prone position	Prone position	Prone position per institutional protocol and as indicated by the treating physician

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clinico Red de Salud UC - Christus; 🇨🇱 Santiago, Region Metropolitana, Chile