COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000740998.aspx

Dr Thomas Melhuish

thomas.melhuish@health.nsw.gov.au

2020-07-16

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

*Adults, over the age of 18 *COVID-19 Diagnosis Confirmed – either by PCR or as per any unit policy changes that may be applied during the enrolment period *Admitted to Intensive Care *Any severity of disease (As defined by National COVID 19 Clinical Evidence Taskforce Australian Guidelines for the clinical care of people with COVID-19 assessable at https://covid19evidence.net.au ). For patients with severe disease, the treating intensivist must be consulted prior to randomisation (see exclusion criterion #2) *Willing and able to tolerate prone positioning (A pre-enrollment screening test to ensure they can tolerate the position and can maneuver into & out of the prone position with minimal assistance from their usual care staff only. ) *Prior informed consent has been obtained from the patient

* Intubated, or expected to be intubated in the next 12 hours * Non Intubated patients with severe disease where the treating intensivist (or an intensivist who is not a study investigator) has any safety concerns regarding the use of prone positioning *Previously intubated for COVID-19, or in the recovery phase of their illness. *Current (or expected) treatment limits such as ‘not for CPR’ or end-of-life care orders *If in the judgment of the treating clinical team there is any other medical condition present which may reduce the safety of the prone positioning. Examples would include pregnancy, concurrent spinal precautions, severe cervical spine arthritis.

2

Royal Prince Alfred Hospital

18

100

Australia

No restriction on type of patients

0: No restriction on type of patients

20

Oxygen Saturations in the blood will be comparedBy assessing the difference in average gradient of the PaO2:FiO2 (PF ratio) in the prone and control groups over the trial period (72 hours). Calculate by pulse oximetry recordings and oxygen delivery method as recorded in the medical chart; calculated by methods describe in the literature; utilising the equation log(P:F Ratio) = 0.48+0.78log(S:F Ratio).[During study period (Study Days 1-3 inclusive) in the intervention group]

Not reported

[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]