Prone Positioning in Non-intubated Patients With Severe COVID-19: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Hospital Civil de Guadalajara
- Enrollment
- 430
- Locations
- 2
- Primary Endpoint
- Intubation rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Miguel Á Ibarra-Estrada
Principal investigator
Hospital Civil de Guadalajara
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
Outcomes
Primary Outcomes
Intubation rate
Time Frame: 28 days
Secondary Outcomes
- Change in the ROX-index 1-hour after first prone session(1 hour)
- Mechanical ventilation days(28 days)
- Adverse effects of prone positioning therapy(28 days)
- Intensive care unit length of stay(28 days)
- Total hours of prone position at day(28 days)
- Total number of prone sessions at day(28 days)
- Hours of the longest prone session each day(28 days)
- Total days of prone positioning therapy(28 days)
- Hospital mortality(28 days)
- Change in oxygenation 1-hour after first prone session(1 hour)
- Hospital length of stay(28 days)