Awake Prone Position for Early Hypoxemia in COVID-19

NCT04344587 | Completed DMC

• 1 other identifier: H-40070
• Study Type: interventional
• Target: 305
• Locations: 2 countries
• Sites: 13

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.

Conditions

COVID-19

Keywords

Prone position; Coronavirus; Inhalation oxygen therapy; Pragmatic Clinical Tria; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Change in respiratory status

  Change in respiratory status will be defined as:1) admission to the ICU and/or a 2) an increase in supplemental oxygen delivery (defined as an increase in oxygen delivery rate of ≥2 liter per minute compared to the oxygen delivery rate at the time of intervention or usual care text message that is sustained for ≥12 or more hours OR the switch to an oxygen delivery method that increases the level of supplemental oxygen.

  up to 30 days

Secondary Outcomes (12)

• Length of time participant spends in the prone position

  up to 30 days

• Length of time participant spends in the supine position

  up to 30 days

• Length of time participant spends lying on side

  up to 30 days

• Length of time participant spends sitting up

  up to 30 days

• Length of time participant spends standing or walking

  up to 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention arm will receive a text message on their smartphones linking to the Qualtrics intervention website

Other: Self-prone position recommendation

Usual care group

ACTIVE COMPARATOR

Participants in the usual care arm will receive a text message on their smartphone linking to the Qualtrics usual care website

Other: Usual care

Interventions

Self-prone position recommendation OTHER

The Qualtrics self-prone position recommendation intervention website will include the following sections: 1. Welcome message 2. Educational review of the potential benefits of prone positioning 3. How-To guide to safely "prone" in a hospital bed 4. A recommendation to "prone" while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours). 5. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking

Intervention group

Usual care OTHER

The Qualtrics usual care website will include the following sections: 1. Welcome message 2. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking

Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston University: lead

Study Sites (13)

Long Beach Medical Center - MemorialCare

Long Beach, California, 90806, United States

Location

Alvarado Hospital

San Diego, California, 92120, United States

Location

St. Joseph's Hospital National Jewish Health

Denver, Colorado, 80218, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Piedmont Atlanta

Atlanta, Georgia, 30309, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Creighton University

Omaha, Nebraska, 68178, United States

Location

Michael E. DeBakey Veteran Affairs Medical Center

Houston, Texas, 77030, United States

Location

VCU Medical Center

Richmond, Virginia, 23219, United States

Location

Hospital Universitario La Paz

Madrid, 28049, Spain

Location

Related Publications (2)

• 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.

  PMID: 33647225 BACKGROUND

• 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.

  PMID: 35597286 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Hypoxia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan J Walkey, MD

  Boston University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: April 23, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); ES (1)