Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Average S/F ratio [48 hours from eligibility]
Average oxygen saturation to fraction of inspired oxygen ratio
- Time spent with S/F ratio < 315 [48 hours from eligibility]
Time spent with oxygenation saturation to fraction of inspired oxygen ratio less than 315
Secondary Outcome Measures
- Highest oxygen support [48 hours from eligibility]
Highest level of supplemental oxygen required
- Number of patients requiring ICU admission during study period [48 hours from eligibility]
Number of patients requiring ICU admission during study period
- Number of patients requiring ICU admission during hospitalization [through study completion, Up to 30 days]
Number of patients requiring ICU admission during hospitalization
- Number of patients experiencing who die prior to discharge [through study completion, Up to 30 days]
Number of patients who die prior to hospital discharge
- Number of patients requiring intubation [48 hours From eligibility]
Number of patients requiring intubation
- Hospital length of stay [through study completion, Up to 30 days]
Number of days from hospital admission to discharge
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Stephanie Taylor, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- Abroug F, Ouanes-Besbes L, Elatrous S, Brochard L. The effect of prone positioning in acute respiratory distress syndrome or acute lung injury: a meta-analysis. Areas of uncertainty and recommendations for research. Intensive Care Med. 2008 Jun;34(6):1002-11. doi: 10.1007/s00134-008-1062-3. Epub 2008 Mar 19.
- Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
- Gattinoni L, Carlesso E, Taccone P, Polli F, Guérin C, Mancebo J. Prone positioning improves survival in severe ARDS: a pathophysiologic review and individual patient meta-analysis. Minerva Anestesiol. 2010 Jun;76(6):448-54. Review.
- Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
- Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgrò S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.
- Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guérin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4. Review.
- Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2.
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
- Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- 06-20-03E