Official Title
Prone Positioning in Non-intubated Patients With Severe COVID-19: a Randomized Controlled Trial
Brief Summary

Besides protective ventilation with low tidal volumes, prone positioning is a proven intervention to decrease mortality in mechanically ventilated patients with moderate-severe acute respiratory distress syndrome. However, the evidence of this strategy in awake non-intubated patients is scarce. The investigators will perform a randomized controlled trial to define if prone positioning can reduce the requirement of mechanical ventilation.

Detailed Description

Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the
treatment of moderate/severe disease is mainly supportive, including oxygen therapy and
invasive mechanical ventilation when impending respiratory failure is established. Moreover,
the associated mortality among mechanically intubated patients is overwhelmingly high. Prone
position relieves the dependent lung regions from the compressive forces of the mediastinum's
weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung
regions. According to a few case series, and observational non-randomized studies with small
sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during
prone positioning, however there are no clinical evidence that this improvement is associated
with a decrease in the risk of invasive mechanical ventilation. Considering that prone
positioning is a low cost, low risk and widely available therapy, more high quality evidence
is needed, to determine if the benefits of prone positioning in awake patients also include a
lower requirement of mechanical ventilation.

Completed
COVID19

Procedure: Awake prone positioning

Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.

Procedure: Standard oxygen therapy

Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%

Eligibility Criteria

Inclusion Criteria:

- Adult patients with confirmed COVID-19, and requirement of a fraction of inspired
oxygen (FiO2) ≥30% through high-flow nasal cannula (HFNC) to maintain a capillary
saturation of ≥90%

Exclusion Criteria:

- Less than 18 years-old

- Pregnancy

- Patients with immediate need of invasive mechanical ventilation

- Contraindications for prone positioning therapy

- Do-not-resuscitate or do-not-intubate order

- Refusal of the patient or decision maker to enroll in the study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Mexico
Locations

Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico

Hospital General de Occidente
Guadalajara, Jalisco, Mexico

Miguel Ibarra-Estrada, Principal Investigator
Investigator

Hospital Civil de Guadalajara
NCT Number
Keywords
Covid-19
severe
Prone positioning
High-flow nasal cannula
MeSH Terms
COVID-19