None listed
Conditions
Brief summary
Prone positioning (lying face down) is a recognised rescue therapy for ventilated patients with severe lung disease whose oxygen levels remain low despite optimal ventilation strategies. We look to investigate whether proning early during admission to the Intensive Care Unit, might improve oxygenation for patient with COVID-19. Objectives: To determine the efficacy and safety of early prone positioning, compared to usual care, on oxygenation for non intubated adults admitted to ICU with COVID-19. Hypothesis: That the intervention (prone positioning) will improve measured oxygen levels in patients with COVID-19
Interventions
Patients enrolled in the intervention arm will be asked to lie prone according to an "intervention plan". In short, they will be enrolled with the aim of lying prone for up to 12 hours a day in a prone position. This time does not have to be continuous and it will be suggested that it is broken into smaller time periods, tailored to each patients level of comfort.
There is no minimum time been period of pruning and no restriction on participants positioning outside of the 'intervention' perio
Patients enrolled in the intervention arm will be asked to lie prone according to an "intervention plan". In short, they will be enrolled with the aim of lying prone for up to 12 hours a day in a prone position. This time does not have to be continuous and it will be suggested that it is broken into smaller time periods, tailored to each patients level of comfort. There is no minimum time been period of pruning and no restriction on participants positioning outside of the 'intervention' periods. If this duration is not tolerated for an individual patient, staff will trial a variety of comfort measures - for example, adding pillow padding under thighs and shoulders, adjusting each patients prone position modified swimmers position and then if required follow a planned ‘de-escalation’ protocol, to find the maximum tolerable proning time for each patient. The intervention will continue for 72 hours (a maximum of 36 hours prone). If a participant is unable to tolerate a 12h/day prone position as above, this can be reduced. A comfortable ‘proning limit’ for each patient can be found and then this can continue for the remaining trial period. Step 1 - Trial 3 x 3hr sessions/9 hours a day Step 2 - If needing longer breaks not prone - Trial 2 x 4hr sessions/8 hours a day Step 3 - Trial 2 x 3hr sessions/6 hours a day Step 4 - 3 x 2 hour sessions/6 hours a day Step 5 - 2 x 2 hours sessions/4 hours a day Step 6 - Abandon proning, document in EMR why proning was abandoned
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*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
Exclusion criteria
* 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.
Outcome results
None listed