ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000740998

Ethics application status

Approved

Date submitted

27/04/2020

Date registered

16/07/2020

Date last updated

16/07/2020

Date data sharing statement initially provided

16/07/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

A Randomised Controlled Trial of Early Prone Positioning to Improve Oxygenation in Non-Intubated Adults Admitted to Intensive Care with COVID-19

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

ROLL OVER COVID Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

SARS-CoV-2

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control groups will receive standard care in our intensive care unit.

It is anticipated most patients will lie i bed supine overnight, perhaps in left or right lateral positions, and then will be sitting upright during periods of the day, possibly out of bed. There will be no restriction on the patients movements or positions in the control group.

Control group

Active

Outcomes

Primary outcome [1]

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).

Timepoint [1]

During study period (Study Days 1-3 inclusive) in the intervention group

Secondary outcome [1]

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

Timepoint [1]

During study period (Study Days 1-3 inclusive) in the intervention group

Secondary outcome [2]

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)

Timepoint [2]

During study period (Study Days 1-3 inclusive) in the intervention group

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealment & randomisation will occur via sequentially numbered opaque sealed envelopes (SNOSE) in a technique described elsewhere. (Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005;20(2):187-91; discussion 91-3.)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be blocked by random permuted blocks to ensure equal allocation, and stratified by single factor, presence of severe disease as defined in the nation consensus guidelines

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

16/07/2020

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital

Address [1]

Missenden Road
Camperdown
NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

Missenden Road
Camperdown
NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Royal Prince Alfred Hospital 
Missenden Road
Camperdown
NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/04/2020

Approval date [1]

18/06/2020

Ethics approval number [1]

Summary

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

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Thomas Melhuish

Address

Intensive Care Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050

Country

Australia

Phone

+61 02 9515 6111

Fax

thomas.melhuish@health.nsw.gov.au

Contact person for public queries

Name

Thomas Melhuish

Address

Intensive Care Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050

Country

Australia

Phone

+61 02 9515 6111

Fax

thomas.melhuish@health.nsw.gov.au

Contact person for scientific queries

Name

Thomas Melhuish

Address

Intensive Care Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050

Country

Australia

Phone

+61 02 9515 6111

Fax

thomas.melhuish@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Our ethical approval application will not include the distribution of IPD.

What supporting documents are/will be available?

Doc. No.	Type	Email
7785	Study protocol	thomas.melhuish@health.nsw.gov.au
7786	Statistical analysis plan	thomas.melhuish@health.nsw.gov.au
7787	Informed consent form	thomas.melhuish@health.nsw.gov.au
7788	Ethical approval	thomas.melhuish@health.nsw.gov.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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