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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Procedure: Standard oxygen therapy; Procedure: Awake prone positioning

• Registration Number: NCT04477655
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Study Start: 2020-05-03
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Primary Completion: 2021-01-26
• Study Completion: 2021-01-26
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard oxygen therapy	Standard oxygen therapy	Oxygen therapy through high flow nasal cannula (HFNC). Continuous monitoring of vital signs. Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%. Prone positioning will be allowed as a rescue therapy.
Awake prone positioning	Awake prone positioning	Oxygen therapy through high flow nasal cannula (HFNC). Patients will be asked to remain in prone position throughout the day as long as possible, with breaks according to tolerance. Pillows will be offered for maximizing comfort at chest, pelvis and knees. Monitoring of vital signs will not be suspended. Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%.

Primary Outcome Measures

Name	Time	Method
Intubation rate	28 days

Secondary Outcome Measures

Name	Time	Method
Change in the ROX-index 1-hour after first prone session	1 hour	The change in the Ratio of Oxygen saturation to respiratory rate (ROX-index)
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

Trial Locations

Locations (2)

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital General de Occidente; 🇲🇽 Guadalajara, Jalisco, Mexico