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Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04547283
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Stephanie Taylor, Atrium Health

Tracking Information
First Submitted Date  ICMJE September 9, 2020
First Posted Date  ICMJE September 14, 2020
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE June 14, 2020
Actual Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Average S/F ratio [ Time Frame: 48 hours from eligibility ]
    Average oxygen saturation to fraction of inspired oxygen ratio
  • Time spent with S/F ratio < 315 [ Time Frame: 48 hours from eligibility ]
    Time spent with oxygenation saturation to fraction of inspired oxygen ratio less than 315
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • Highest oxygen support [ Time Frame: 48 hours from eligibility ]
    Highest level of supplemental oxygen required
  • Number of patients requiring ICU admission during study period [ Time Frame: 48 hours from eligibility ]
    Number of patients requiring ICU admission during study period
  • Number of patients requiring ICU admission during hospitalization [ Time Frame: through study completion, Up to 30 days ]
    Number of patients requiring ICU admission during hospitalization
  • Number of patients experiencing who die prior to discharge [ Time Frame: through study completion, Up to 30 days ]
    Number of patients who die prior to hospital discharge
  • Number of patients requiring intubation [ Time Frame: 48 hours From eligibility ]
    Number of patients requiring intubation
  • Hospital length of stay [ Time Frame: through study completion, Up to 30 days ]
    Number of days from hospital admission to discharge
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19
Official Title  ICMJE Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19: A Pilot Randomized Controlled Trial
Brief Summary This study aims to determine if a strategy of recommending prone (on stomach) positioning of patients positive or suspected positive for coronavirus disease 2019 (COVID-19) requiring supplemental oxygen, but not mechanically ventilated, Is feasible in the inpatient setting. This study will be performed as a pragmatic pilot clinical trial to gain information relevant to the future conduct of a larger trial.
Detailed Description

Severe acute respiratory syndrome coronavirus-2, SARS-CoV-2, the virus causing coronavirus disease 2019 (COVID-19) pandemic, has rapidly led to significant morbidity and mortality worldwide, primarily through lower respiratory tract involvement progressing from hypoxemia to acute respiratory distress syndrome. Novel approaches to improving oxygenation are urgently needed to limit aerosolization concerns and resource scarcity associated with intubation and, to a lesser extent, other forms of advanced respiratory support.

Prone positioning in mechanically ventilated patients with hypoxemic respiratory failure has been associated with improvement in oxygenation and mortality in patients with acute respiratory distress syndrome (ARDS). The prone position appears to provide more uniform lung perfusion, shifting ventilation to well-perfused lung segments and recruitment of dependent atelectatic regions of lung. Physiological alterations associated with the prone position would foreseeably also apply to spontaneously breathing patients and evidence from small observational studies suggests that prone positioning in non-intubated patients is feasible associated with improvement in oxygenation. However, it remains unknown if a prone ventilation strategy is truly beneficial for non-intubated hypoxic Covid-19 patients, and this question has stimulated interest in the conduct of rigorous randomized controlled trials (RCT).

However, the awake prone strategy is a complex medical intervention with multiple implementation nuances such as adoption, feasibility, and tolerability that may affect successful conduct of a definitive RCT. In order to increase the likelihood of a successful future RCT, the investigators will conduct the APPS pilot study. The overall aim of the APPS pilot trial was to assess feasibility and important contextual factors for a large RCT to compare the clinical effectiveness of an Awake-Prone Positioning Strategy (APPS) for respiratory support versus usual care alone for hypoxic adults with Covid-19.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Clinicians were unblinded to treatment allocation and enrolled patients were considered unblinded. Clinical and safety outcomes were collected from the electronic health record by study investigators blinded to treatment assignment.
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Respiratory Failure
Intervention  ICMJE
  • Other: Usual Care
    No clinical team recommendation, patients will remain in their natural choice of position
  • Other: APPS
    Clinical team guidance on prone positioning of patients
Study Arms  ICMJE
  • Active Comparator: Usual Care
    Participants randomized to this arm will remain in their clinician's team standard practice and their natural choice of position, which is anticipated to favor a supine (rather than prone) position.
    Intervention: Other: Usual Care
  • Experimental: Awake-Prone Positioning Strategy
    Participants randomized to this arm will receive guidance from their Inpatient treatment team to assume the prone position for as much time as is tolerable during hospitalization.
    Intervention: Other: APPS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • hospitalized patients with positive COVID testing during hospitalization or 7 days prior OR Hospitalized with suspected COVID pneumonia
  • room air oxygen saturation <93% or oxygen requirement > or equal to 3 Liters per minute

Exclusion Criteria:

  • unable to turn self, spinal instability, facial or pelvic fractures, open chest or open abdomen, altered mental status, anticipated difficult airway, show signs of respiratory fatigue, or receiving end-of-life care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04547283
Other Study ID Numbers  ICMJE 06-20-03E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual patient data underlying reported results will be made available with data dictionaries after de-identification.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
Access Criteria: Data will be accessible to researchers who provide a methodologically sound proposal After approval by the AtriumHealth Institutional Review Board and the study investigators.
Responsible Party Stephanie Taylor, Atrium Health
Study Sponsor  ICMJE Atrium Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Taylor, MD Atrium Health
PRS Account Atrium Health
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP