Skip to main content
OpenTrials
Completed

NCT Number: NCT04641182

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone position

Other

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

Primary outcomes

  1. Therapeutic failure

    Time frame: At 14 days

    Defined by death or intubation or use of non-invasive ventilation

  2. Mortality

    Time frame: At day 28

    Number of patients that die

  3. Length of hospital stay

    Time frame: At 28 days

    Number of days spent by the patients at the hospital

  4. Days requiring high flow nasal oxygen

    Time frame: At 28 days

    Number of days the patients require high flow nasal oxygen therapy

  5. Days requiring supplemental oxygen

    Time frame: At 28 days

    Number of days the patients require supplementary oxygen

  6. Displacement of invasive devices during position changes

    Time frame: At 28 days

    Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes

  7. Occurrence of pressure ulcers on the anterior surface of the body

    Time frame: At 28 days

    Number of patients that develope pressure ulcers on the anterior surface of the body

Secondary outcomes

  1. Respiratory superinfection

    Time frame: At 28 days

    Certified by a respiratory tract sample and culture

  2. Delirium

    Time frame: At 28 days

    Defined by the Confusion Assessment Method (CAM)

  3. Caloric intake

    Time frame: At 28 days

    Daily number of ingested calories (in kilocalories) by the patients is recorded

  4. Proteic intake

    Time frame: At 28 days

    Daily number of ingested proteins (in grams) by the patients is recorded

Other outcomes

  1. Dyspnea

    Time frame: At 28 days

    Using a scale from 1 to 10 (from 1 no dyspnea to 10 maximum dyspnea)

  2. Comfort with the position

    Time frame: At 28 days

    Using a scale from 1 to 4 (1 is very comfortable and 4 is very uncomfortable)

  3. Oxygen saturation

    Time frame: At 28 days

    Using PAFI (PAFI: Index calculated by Pressure of Arterial Oxygen / Inspired Fraction of Oxygen)

  4. Oxygen saturation

    Time frame: At 28 days

    Using SAFI (SAFI: Index calculated by Oxygen Saturation by Pulse Oximetry / Inspired Fraction of Oxygen)

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 23, 2020
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.