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OpenTrials
Completed

NCT Number: NCT04477655

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Awake Prone Positioning

Procedure

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

Standard oxygen therapy

Procedure

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

Primary outcomes

  1. Intubation rate

    Time frame: 28 days

Secondary outcomes

  1. Total hours of prone position at day

    Time frame: 28 days

  2. Total number of prone sessions at day

    Time frame: 28 days

  3. Hours of the longest prone session each day

    Time frame: 28 days

  4. Change in oxygenation 1-hour after first prone session

    Time frame: 1 hour

  5. Change in the ROX-index 1-hour after first prone session

    Time frame: 1 hour

    The change in the Ratio of Oxygen saturation to respiratory rate (ROX-index)

  6. Total days of prone positioning therapy

    Time frame: 28 days

  7. Adverse effects of prone positioning therapy

    Time frame: 28 days

  8. Mechanical ventilation days

    Time frame: 28 days

  9. Intensive care unit length of stay

    Time frame: 28 days

  10. Hospital length of stay

    Time frame: 28 days

  11. Hospital mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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

Acronym: PRO-CARF

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Apr 13, 2021

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.

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