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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

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.

Condition or disease Intervention/treatment Phase
Covid19 Respiratory Failure Other: Usual Care Other: APPS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19: A Pilot Randomized Controlled Trial
Actual Study Start Date : June 14, 2020
Actual Primary Completion Date : September 20, 2020
Actual Study Completion Date : September 30, 2020

Arm Intervention/treatment
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.
Other: Usual Care
No clinical team recommendation, patients will remain in their natural choice of position

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.
Other: APPS
Clinical team guidance on prone positioning of patients




Primary Outcome Measures :
  1. Average S/F ratio [ Time Frame: 48 hours from eligibility ]
    Average oxygen saturation to fraction of inspired oxygen ratio

  2. 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


Secondary Outcome Measures :
  1. Highest oxygen support [ Time Frame: 48 hours from eligibility ]
    Highest level of supplemental oxygen required

  2. Number of patients requiring ICU admission during study period [ Time Frame: 48 hours from eligibility ]
    Number of patients requiring ICU admission during study period

  3. 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

  4. 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

  5. Number of patients requiring intubation [ Time Frame: 48 hours From eligibility ]
    Number of patients requiring intubation

  6. Hospital length of stay [ Time Frame: through study completion, Up to 30 days ]
    Number of days from hospital admission to discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547283


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Stephanie Taylor, MD Atrium Health
Publications:

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Responsible Party: Stephanie Taylor, Associate Professor, Atrium Health
ClinicalTrials.gov Identifier: NCT04547283    
Other Study ID Numbers: 06-20-03E
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases