Awake Prone Positioning for Non-intubated COVID-19 Patients
Condition: Prone Position; Coronavirus Disease 2019; Oxygenation
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The burden of coronavirus disease 2019 (COVID-19) pandemic is still on a rising course making
      a great stress on medical resources throughout the world. Although most of COVID-19 patients
      require non-invasive oxygenation and ventilation, rapid progression to hypoxemic respiratory
      failure and then acute respiratory distress syndrome (ARDS) can occur in some COVID19
      patients due to prolonged or unaddressed hypoxia. Prone positioning is a common supportive
      ventilation strategy to improve oxygenation in critically ill patients with ARDS. Recent
      studies point out the potential benefits of using this strategy for non-intubated awake COVID
      19 patients who are hypoxic. Despite several retrospective cohort studies have been conducted
      to identify impact of the prone positioning in awake non-intubated COVID-19 patients,
      experimental studies are very rare. This study therefore aims to evaluate the effects of
      self-prone positioning on oxygenation and physiological outcomes among awake-non intubated
      patients with COVID-19.
    

Detailed description: 
      A randomised controlled trial design will be adopted to achieve the aim of the current study.
      In this study 82 adult patients of either sex with a confirmed diagnosis of COVID-19 will be
      recruited from general intensive care unit of the chest hospital (affiliated to the Ministry
      of Health) in Damanhour city, El Beheira Governorate, Egypt. Patients will be enrolled in the
      current study if they meet study inclusion criteria.

      The eligible patients will be randomly assigned into two groups (control and intervention
      group) 41 patients in each. The control group will receive the standard management of
      COVID-19 patients according to the Egyptian Ministry of health guidelines. The standard
      management includes supplemental oxygen or non-invasive continuous positive airway pressure
      (CPAP), antivirals, antibiotics, anticoagulants and glucocorticoids, as necessary, based on
      the patients' clinical condition. Patients in the control group will be subjected to the
      conventional positioning interventions provided by the critical care nurses, which will not
      include self-prone positioning.

      Patients in the intervention group will receive self-prone positioning and standard
      management of COVID-19 patients. All patients in both groups (control and intervention) will
      be monitored continuously by cardiac monitoring with oxygen saturation (SpO2) during the
      study period. The demographic and baseline clinical data of all eligible patients will
      collected and recorded using the study tool.

      Each patient in the intervention group will be helped into the prone position and encouraged
      to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning
      consists of placing the patient on his or her stomach with the head on the side. Self-prone
      position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side
      effects. The patient will be maintained in prone position until the patient becomes too tired
      and uncomfortable to keep that position. If patients will asked to regain the supine position
      before the 1 hour period was complete, patient's prone position will be considered unfeasible
      and the reason will be reported. Patients who required invasive mechanical ventilation at any
      time point will be intubated and excluded from the study.

      The effect of patients' positioning on oxygenation and physiological parameters will be
      collected and recorded. These parameters include vital signs (respiratory rate, systolic
      blood pressure, diastolic blood pressure and heart rate), SpO2, oxygenation index (PaO2/FiO2
      ratio), ROX index (combination of the ratio of oxygen saturation measured by pulse oximetry
      to fraction of inspired oxygen and respiratory rate [SpO2/FiO2]/respiratory rate) and
      arterial blood gases parameters (pH, PaO2mmHg, PaCO2mmHg and SaO2). These parameters will be
      recorded before and after positioning (immediately before, after 10 minutes and after 1hour).
      Data of secondary outcomes of self-prone positioning will also be collected and recorded.
    

Intervention name(s): prone position group
Intervention type(s): Procedure
Intervention description(s): Patients randomized to this arm will receive self-prone positioning. Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental research design
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care