Clinical trial NCT04408222: Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure
Official title: Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Deficiency
Coronavirus Infection
Keywords: Awake Proning
COVID-19
SARS-CoV-2
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with laboratory-confirmed COVID-19 infection who were admitted to the step-down unit at the Columbia University Irving Medical Center in New York between April 6 and 14, 2020 were included. A confirmed case of COVID-19 was defined by a positive result on a reverse transcriptase-polymerase chain reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab. Only laboratory-confirmed cases were included.

Brief summary: The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.

Detailed description: Critically ill patients with coronavirus disease 2019 (COVID-19) severely strained intensive care resources in New York in April 2020. The prone position improves oxygenation in intubated patients with acute respiratory distress syndrome. The investigators wanted to study whether the prone position is associated with improved oxygenation and decreased risk for intubation in spontaneously breathing patients with severe COVID-19 hypoxemic respiratory failure. Awake prone positioning was implemented based on the health care provider decision.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients admitted to the Columbia University step-down unit from April 6, 2020.
* Laboratory confirmed COVID-19 infection with severe hypoxemic respiratory failure defined as respiratory rate ≥30 breaths/min and oxyhemoglobin saturation (SpO2) ≤93% while receiving supplemental oxygen 6 L/min via nasal cannula and 15 L/min via non-rebreather facemask.

Exclusion Criteria:

* Altered mental status with inability to turn in bed without assistance
* Extreme respiratory distress requiring immediate intubation, or oxygen requirements less than specified in the inclusion criteria.

Primary outcomes:
measure: Change in SpO2
timeFrame: Before proning and 1 hour after initiation of the prone position
Secondary outcomes:
measure: Mean Risk Difference in Intubation Rates
timeFrame: Duration of hospitalization or up to 1 month from admission
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Sanja Jelic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerin 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.
citation: Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
citation: 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. No abstract available.
citation: Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y. No abstract available.
citation: 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.
citation: https://www1.nyc.gov/site/doh/Covid/Covid-19-data.page; Accessed April 17, 2020.