Timed Awake Prone and Repositioning for Patients With Covid-19-induced Hypoxic Respiratory Failure.

Study Overview
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Brief Summary
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Awake prone positioning has been reported to improve oxygenation for patients with COVID-19. Awake timed and repositioning is a novel method to improve patients' compliance and prolong the prone time. This study aims to explore the impact of timed prone and repositioning on the intubation rate and prognosis of COVID-19 patients with hypoxic respiratory failure.

Detailed Description
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Patients with COVID-19 may develop severe illness characterized by progressive hypoxic respiratory failure, resulting in the need for invasive mechanical ventilation. Reducing the rate of endotracheal intubation in patients with hypoxic respiratory failure can be beneficial to the prognosis, economize iatrical resources and reduce sanitary investment. Some studies have shown that prone positioning can improve oxygenation to some extent in patients receiving invasive mechanical ventilation due to severe ARDS. Whether awake prone positioning can reduce endotracheal intubation and mortality in COVID-19 patients with hypoxic respiratory failure is still controversial. A meta-analysis found that the awake prone positioning was safe and feasible to reduce the risk of intubation or death. However, the multicenter randomized controlled trial (RCT) conducted by Alhazzani et al pointed out that the awake prone positioning group did not significantly reduce the rate of endotracheal intubation when compared with the standard of care. Some researchers thought the time of prone positioning is an important factor for the different results. In previous studies, the median duration of prone positioning was only 4.8-5 hours per day but some guidelines recommend the duration should be more than 8 hours. Therefore, increasing patient adherence in the awake prone positioning and extending prone positioning time are of great importance. Awake timed prone and repositioning is a novel method proposed in recent years, which can improve patients' compliance and prolong the time of treatment. This study intends to ask whether awake timed prone and repositioning could impact the intubation rate and prognosis of unincubated patients with hypoxic respiratory failure induced by COVID-19.

Official Title
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Efficacy of Timed Awake Prone and Repositioning in Patients With Covid-19-induced Hypoxic Respiratory Failure: a Multi-center, Randomized Controlled Trial.

Conditions
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Corona Virus Infection, Hypoxic Respiratory Failure

Intervention / Treatment
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* Behavioral: Awake timed prone and repositioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years of age Awake patients without endotracheal intubation Suspected or confirmed infection of COVID-19 Hypoxemia requiring oxygen supplementation ≥ 0.4 FiO2 or ≥ 5L/min via nasal cannula Bilateral or unilateral chest infiltrates on x-ray or HRCT Admitted to the ICU or an acute care unit where hemodynamic and respiratory Willingness to comply with the protocol and provide written informed consent Exclusion Criteria: Risk of airway obstruction or even asphyxia Need for emergent intubation after admission Respiratory failure caused by cardiogenic pulmonary edema Unable to implement timed prone and repositioning due to any cause Injury or wound on the ventral body surface affecting the prone position Unstable fracture of cervical vertebra and spine Glaucoma or other sharp increases in intraocular pressure Intracranial hypertension caused by traumatic brain injury etc. Significantly high risk of pulmonary embolism Acute hemorrhagic disease Respiratory rate >40 breaths/min, with significant dyspnea Transcutaneous oxygen saturation can not be continuously monitored Hemodynamic instability requiring vasoactive drugs (systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg despite adequate volume resuscitation) Awareness disorder or inability to accept instructions, communication barrier with the nursing team, inability to use language or pager to call for help Difficulty or limitation in autonomous movement, inability to adjust the position without assistance from others Body mass index > 37 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Awake timed prone and repositioning group<br>Patients' cumulative prone and repositioning time is encouraged to reach 8-10 hours per day for 4 days following a timed prone and repositioning strategy. | Behavioral: Awake timed prone and repositioning<br>* Patients were instructed to adopt a timed prone and repositioning strategy with 4 sessions for four consecutive days. Session 1, lying on the belly; Session 2, lying on the right side; Session 3, sitting up; Session 4, lying on the left side; then back to session 1 (30 minutes to two hours for each session). The daily duration of timed prone and repositioning is strongly recommended for 8-10 hours.<br>|
| No Intervention: Standard care group<br>Patients can change their positions freely according to their own needs. Health providers do not take the initiative to give guidance on prone and repositioning. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal Intubation rate | The incidence of endotracheal Intubation within 30 days of study enrollment | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause death within 30 days of study enrollment | Day 30 | 
| Days of non-invasive ventilation | Number of days alive and free of mechanical ventilation within 30 days of study enrollment | Day 30 | 
| Days alive and outside the ICU | Number of days alive and outside the ICU within 30 days of study enrollment | Day 30 | 
| Clinical events | Clinical events include time to treatment failure( treatment failure defined as intubation or death); time to intubation; time to death; duration of invasive mechanical ventilation in intubated patients surviving to day 30; mortality in invasively mechanically ventilated patients; and physiological response to awake prone positioning, including the ratio of SpO2:FiO2 to respiratory rate, known as the ROX index. | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awake prone positioning