Prone Positioning for Patients on General Medical Wards With COVID19

STATUS

Recruiting
participants needed

350
sponsor

St. Michael's Hospital, Toronto

Send

Updated on 19 February 2024

See if I qualify

mechanical ventilation

FIO2

covid-19

nosocomial infection

fraction of inspired oxygen (fio2)

Summary

Show definitions

COVID-PRONE is a multicenter, pragmatic, single-blind, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.

Description

COVID-PRONE is a multicenter, pragmatic, single-blind, 2-arm, parallel, randomized controlled trial. The intervention is not a medication or a medical device. Instead, the intervention is instructing patients to lie on their stomach while they are in bed.

Patients will be randomized to receive either standard-of-care or pre-emptive prone positioning while in bed (target > 12 hours per day) plus standard of care. Randomization will be stratified by site. Patients randomized to prone positioning will be instructed to i) lie on their stomach supported by their arms and a pillow at the level of their shoulders and another pillow at the level of the pelvis, ii) immediately thereafter their oxygen saturation will be checked, iii) after a two hour period they can reposition to supine (but should be educated on the use of prone position and encouraged to adopt prone position as often as tolerated while in bed); the 2-hour period will be encouraged four times each day in addition to during sleep overnight.

Since there are limited data on the potential risks and benefits of prone positioning, a feasibility analysis will be performed after 30 patients are randomized to identify the rate of serious adverse events in the prone group (e.g., rate of pneumonia, death, intubation) and to understand the change in oxygenation as a result of prone positioning.

Details

Condition	ADULT RESPIRATORY DISTRESS SYNDROME, Covid 19
Age	18years - 100years
Treatment	Prone positioning
Clinical Study Identifier	NCT04383613
Sponsor	St. Michael's Hospital, Toronto
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients 18 years of age
	Confirmed diagnosis of COVID-19 [or highly suspected and awaiting result]
	Able to lie on their stomach with verbal instruction
	Requiring supplemental oxygen less than 50% FiO2
	Capable to make treatment related decisions
Exclusion Criteria
	Inability to follow commands (e.g., delirium, dementia)
	indication for mechanical ventilation (e.g., reduced level of consciousness, rapid clinical deterioration)
	contraindication to prone positioning (spinal cord injury, unstable c-spine, pelvic fracture, unstable airway, open chest or abdomen, anterior chest tube, recent abdominal surgery in past 14 days)
	patients on home CPAP (continue positive airway pressure)
	transfer from ICU in past 72 hours
	need for telemetry at the time of randomization
	pregnant (i.e., more than 20 weeks)
	body mass index above 40 kg/m2 (based on clinician's assessment)
	Recently completed or plan for intrathoracic or intra-abdominal surgical procedure
	severe hemoptysis
	pace-maker inserted in past 48 hours

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

mechanical ventilation

FIO2

covid-19

nosocomial infection

fraction of inspired oxygen (fio2)

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Prone Positioning for Patients on General Medical Wards With COVID19