Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19
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| ClinicalTrials.gov Identifier: NCT04547283 |
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Recruitment Status :
Completed
First Posted : September 14, 2020
Last Update Posted : April 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 Respiratory Failure | Other: Usual Care Other: APPS | Not Applicable |
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 : | 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 |
|---|---|
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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.
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Other: Usual Care
No clinical team recommendation, patients will remain in their natural choice of position |
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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.
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Other: APPS
Clinical team guidance on prone positioning of patients |
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Principal Investigator: | Stephanie Taylor, MD | Wake Forest University Health Sciences |
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT04547283 |
| Other Study ID Numbers: |
06-20-03E |
| First Posted: | September 14, 2020 Key Record Dates |
| Last Update Posted: | April 21, 2022 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Respiratory Insufficiency Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders |