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Completed

NCT Number: NCT04547283

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

No clinical team recommendation, patients will remain in their natural choice of position

APPS

Other

Clinical team guidance on prone positioning of patients

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19: A Pilot Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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