Clinical trial NCT04344587: Awake Prone Position for Early Hypoxemia in COVID-19
Official title: Awake Prone Position for Early Hypoxemia in COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Prone position
Coronavirus
Inhalation oxygen therapy
Pragmatic Clinical Tria
Hypoxia
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission.

The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.

Detailed description: The purpose of this multi-site trial is to investigate the use of prone positioning in SARS-CoV-2 infected patients who are not intubated. The APPEX-19 study is a pragmatic adaptive randomized controlled unblinded trial. The study compares a smartphone tool that recommends non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) to usual care.

Participants who are assigned to the intervention arm will receive a text message containing a link to an online website that reviews how to safely self-prone position and a recommendation to self-prone position 4 times for 1-2 hours each during the day and at night every 24 hours. Participants will also receive twice daily reminders to self-prone using the same smartphone platform.

All participants will receive twice daily Qualtrics online surveys to answer questions about which body positions they used in bed and their level of comfort and shortness of breath. Participants will receive these twice daily text messages until they are discharged, until they are transferred to the ICU, until they die, until their lung function declines, or until 14 days pass since enrollment. Thus, most participants will receive twice daily text messages for about 1 week; it is expected that almost all patients will receive twice daily text messages for no longer than 14 days. Medical charts will be reviewed daily to track routine clinical data to determine outcomes.

Boston Medical Center (BMC) / Boston University will be one of the 16 sites and the data coordinating center for this multisite trial. The unique design of the study means that if evidence accumulates that one treatment is better than the other, more participants will be chosen to receive the prone position intervention that works over time. Thus, the trial will both show what works, implement what works, and make sure that the most participants receive the treatment that works.

Eligibility criteria: Inclusion Criteria:

* Assigned to or admitted to a COVID-19 ward team at a participating site (these teams only admit patients who are under investigation for COVID-19 or who have confirmed COVID-19 infection) via the emergency department (ED) within the last 24 hours
* Have access to their own functioning smartphone in the hospital room
* English or Spanish-speaking
* Ability to read simple instructions and answer simple written questions

Exclusion Criteria:

Baseline patient factors

* Inability to operate the hospital bed
* Inability to lie flat comfortably
* Inability to lie flat without shortness of breath
* Inability to turn over independently

Medical comorbidities

* Hemoptysis in the last 2 days
* Prior lung transplant
* Dementia

Acute issues

* Deep venous thrombosis treated for less than 2 days
* Unstable spine, femur, or pelvic fractures
* Mean arterial pressure lower than 65 mmHg
* Receiving ≥6 liters per minute of supplemental oxygen via nasal cannula, nasal pendant, or shovel mask
* Receiving supplemental oxygen via more aggressive methods (e.g. Venturi mask or non-rebreather mask)

Recent interventions

* Chest tube in place
* Tracheal surgery or sternotomy during the previous 15 days
* Serious facial trauma or facial surgery during the previous 15 days
* Cardiac pacemaker inserted in the last 2 days

Other

* Pregnancy
* Comfort measures only status
* Prisoner

Primary outcomes:
measure: Change in respiratory status
timeFrame: up to 30 days
Secondary outcomes:
measure: Length of time participant spends in the prone position
timeFrame: up to 30 days
measure: Length of time participant spends in the supine position
timeFrame: up to 30 days
measure: Length of time participant spends lying on side
timeFrame: up to 30 days
measure: Length of time participant spends sitting up
timeFrame: up to 30 days
measure: Length of time participant spends standing or walking
timeFrame: up to 30 days
measure: Dyspnea or difficult/labored breathing
timeFrame: up to 30 days
measure: Discomfort with proning
timeFrame: up to 30 days
measure: Length of hospital stay
timeFrame: up to 30 days
measure: Invasive mechanical ventilation
timeFrame: up to 30 days
measure: Loss of IV access as a consequence of turning in bed
timeFrame: up to 30 days
measure: Acute respiratory distress syndrome (ARDS) diagnosis
timeFrame: up to 30 days
measure: Hospital mortality
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Medical Center - MemorialCare
state: California
city: San Diego
country: United States
facility: Alvarado Hospital
state: California
city: Denver
country: United States
facility: St. Joseph's Hospital National Jewish Health
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Piedmont Atlanta
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Houston
country: United States
facility: Michael E. DeBakey Veteran Affairs Medical Center
state: Texas
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Boston University
name: Allan J Walkey, MD
role: STUDY_DIRECTOR
References:
citation: Garcia MA, Rampon GL, Doros G, Jia S, Jagan N, Gillmeyer K, Berical A, Hudspeth J, Ieong M, Modzelewski KL, Schechter-Perkins EM, Ross CS, Rucci JM, Simpson S, Walkey AJ, Bosch NA. Rationale and Design of the Awake Prone Position for Early Hypoxemia in COVID-19 Study Protocol: A Clinical Trial. Ann Am Thorac Soc. 2021 Sep;18(9):1560-1566. doi: 10.1513/AnnalsATS.202009-1124SD.
citation: Rampon G, Jia S, Agrawal R, Arnold N, Martin-Quiromicrons A, Fischer EA, Malatack J, Jagan N, Sergew A, Case AH, Miller K, Tanios M, Doros G, Ross CS, Garcia MA, Gillmeyer KR, Griffiths NG, Jandali B, Modzelewski KL, Rucci JM, Simpson SQ, Walkey AJ, Bosch NA. Smartphone-Guided Self-prone Positioning vs Usual Care in Nonintubated Hospital Ward Patients With COVID-19: A Pragmatic Randomized Clinical Trial. Chest. 2022 Oct;162(4):782-791. doi: 10.1016/j.chest.2022.05.009. Epub 2022 May 18.