An interventional study of Awake timed prone and repositioning in Corona Virus Infection and Hypoxic Respiratory Failure, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's planned enrollment of 286 is above the median of 107 across 541 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Endotracheal Intubation rate
The incidence of endotracheal Intubation within 30 days of study enrollment
Time frame: Day 30
Mortality
All-cause death within 30 days of study enrollment
Time frame: Day 30
Days of non-invasive ventilation
Number of days alive and free of mechanical ventilation within 30 days of study enrollment
Time frame: Day 30
Days alive and outside the ICU
Number of days alive and outside the ICU within 30 days of study enrollment
Time frame: 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.
Time frame: Day 30
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University