COVID-19 trials registries data warehouse

https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052387

Jose Vidal-Mayo

interstrok@hotmail.com

2021-10-27

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients in palliative care2. Patients with imminent orotracheal intubation according to refractory hypoxemia with acute respiratory distress syndrome (ARDS), acute respiratory acidosis (pH &lt, 7.15, PaCO2 &gt,45 mmHg) with ARDS, requirement of airway protection.3. Patients with unsolved shock (reanimation phase or norepinephrine dose greater than or equal to 0.15 mcg/kg/min).4. Unstable arrythmias (bradycardia o tachycardia).5. Mental agitation or altered mental state (Glasgow Comma Scale &lt,10 points) that would impede cooperation to self-prone.6. Instability of the pelvis, vertebral column, or femur due to recent surgery or trauma. 7. Anatomical alterations that limit the adoption of prone position (severe kyphoscoliosis, muscle contracture, or other).8. Abdominal surgery in the last 15 days.9. Thoracic lesion or surgery in the last 15 days. 10. Pregnancy11. Intracranial hypertension 12. Deep vein thrombosis in the last 2 days. 13. Heart pacemaker surgery in the last 2 days. 14. Chest tube with air leak 15. Recent facial trauma or surgery16. Morbid obesity (BMI &gt,40 kg/m2)17. Pressure lesions or ulcers

2

Mexican Secretariat of Health Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Intensive Care Unit

18

100

Mexico

Severe disease at enrollment

6: Severe disease at enrollment

384

1. Proportion of patients with orotracheal intubation and invasive mechanical ventilation performed up to 28 days after randomization.2. Proportion of patients who die up to 28 days after randomization.

Not reported

[{"arm_notes": "", "treatment_id": 1751, "treatment_name": "Awake prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1247, "treatment_name": "Supine position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]