COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05689216

Yuanyuan Yao, M.D.

yuanyuan58@126.com

2023-01-19

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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

2

Second Affiliated Hospital, School of Medicine, Zhejiang University

18

100

China

Critical disease at enrollment

8: Critical disease at enrollment

286

Endotracheal Intubation rate

None

Not reported

[{"arm_notes": "nan", "treatment_id": 1751, "treatment_name": "Awake prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]