A Study of Lying Face Down to Help Improve Oxygen Levels of Adults Not Needing Ventilators in Intensive Care with COVID-19

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: 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 CONDITION: COVID‐19;SARS‐CoV‐2; ; COVID‐19 ; SARS‐CoV‐2 Infection ‐ Other infectious diseases Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: Oxygen Saturations in the blood will be compared; ; By 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] SECONDARY OUTCOME: Median number of hours spent prone per day during trial period in the intervention group, as recorded in the medical chart by the treating nurse[During study period (Study Days 1‐3 inclusive) in the intervention group] Number of adverse events in the prone group compared to control, as collected by staff survey, and any other incidence of adverse events brought to the attention of investigators. ; ; For example we are collection information on the incidence of: ; Dislodgement of supplemental oxygen delivery device ; Dislodgement of Venous Access ; Dislodgement of Arterial Access ; Dislodgement of Another Catheter (IDC, Chest tube etc.) ; New Pressure Area (not present/recorded at start of trial) (Stage of Pressure Area – as per the National Pressure Ulcer Advisory Panel (NPUAP) 2016 Pressure Injury Staging Illustrations) ; Facial Oedema ; Required sedation for agitation ; Hypotension on repositioning ; Desaturation ‐ not requiring a change in management ; Desaturation ‐ requiring a change in management e.g. increased FiO2 ; Vomiting ; Arrhythmias ; Cardiac Arrest ; Other (Free text) ; [During study period (Study Days 1‐3 inclusive) in the intervention group] 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 *Prior informed consent has been obtained from the patient *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. )
Epistemonikos ID: ee12fe097092993e2d299c1435e854328a0064c7
First added on: Jul 23, 2020