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Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04477655
Acronym
PRO-CARF
Enrollment
430
Registered
2020-07-20
Start date
2020-05-03
Completion date
2021-01-26
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID-19, Severe, Prone positioning, High-flow nasal cannula

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.

Interventions

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

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

Sponsors

Hospital Civil de Guadalajara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intubation rate28 days

Secondary

MeasureTime frameDescription
Total number of prone sessions at day28 days
Hours of the longest prone session each day28 days
Change in oxygenation 1-hour after first prone session1 hour
Change in the ROX-index 1-hour after first prone session1 hourThe change in the Ratio of Oxygen saturation to respiratory rate (ROX-index)
Total days of prone positioning therapy28 days
Total hours of prone position at day28 days
Mechanical ventilation days28 days
Intensive care unit length of stay28 days
Hospital length of stay28 days
Hospital mortality28 days
Adverse effects of prone positioning therapy28 days

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026