Clinical trial NCT05957588: Non-ventilated Prone Positioning in the COVID-19 Population
Official title: Non-ventilated Prone Positioning in the COVID-19 Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Proning
Oxygenation
Length of Stay
Keywords: acute care
self-proning
Lead sponsor: Baylor St. Luke's Medical Center
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a prospective randomized cohort study in which data was collected for over 14 days or until discharged to a lower level of care from the telemetry-monitored, acute care unit. Data collected on study participants included the need for escalating respiratory care as well as length of stay in the acute care unit. Comparative analysis was conducted with data collected from hospitalized patients (the control group) with a diagnosis of COVID-19 on a non-ICU acute care, telemetry-monitored unit that met the hypoxemia criteria, but that did not receive the proning intervention. The data from the control group was collected by a retrospective chart analysis after 14 days.
Primary purpose: PREVENTION

Brief summary: In the COVID-19 healthcare crisis, one possible treatment therapy that has generated the most discussion is that of proning, or the position in which the patient lays face down as opposed to face up for a period of time. As the pandemic continues, this method has been more widely adopted to increase oxygen saturation in patients in respiratory distress. While proning research is both ongoing and extensive in the ICU population of COVID-19 patients, minimal research has been conducted with acute care patients. The researchers aim to address this gap with this study. The researchers used a systematic approach to educate patients and staff about patient self-proning, implementing self-proning every 2 hours, and monitoring escalation of oxygen levels, as well as length of stay in the acute care unit. The researchers hypothesized an improvement in oxygen saturation levels as evidenced by no escalation of respiratory care (i.e. higher levels of oxygen needed, transfer to higher level of care), resulting in shorter lengths of stay for the intervention population.

Detailed description: Background: In the COVID-19 healthcare crisis, one possible treatment therapy that has generated the most discussion is that of proning, or the position in which the patient lays face down as opposed to face up for a period of time. As the pandemic continues, this method has been more widely adopted to aid in increasing oxygen saturation levels in patients in respiratory distress. While proning research is both ongoing and extensive in the ICU population of COVID-19 patients, minimal research has been conducted using acute care patients. The researchers aim to address this gap with this treatment method.

Methods: This study was a randomized controlled trial with a sample size of 216 patients, with 36 self-proners, 104 standard of care patients, and 69 patients refused to participate in the intervention. The researchers also studied rates of attrition for self-proning. Patients were randomized using a randomization table per hospital admission. The researchers consented patients who were oriented, and able to self-prone safely without assistance on an acute care telemetry monitored unit. Patients were self-documenting their position per hour, and the researchers were using the electronic health record to collect vital signs and presence of pressure injuries. All data was entered in the secure REDCap database.

Eligibility criteria: Inclusion Criteria:

* patients that were confirmed COVID-19 positive on an acute-care, telemetry-monitored, non-ICU unit and were considered hypoxemic
* conscious, oriented and independently mobile patients
* subjects were patients 18 years and older

Exclusion Criteria:

* negative for COVID 19
* patients in ICU settings
* patients in acute respiratory distress
* patients in hemodynamic instability (systolic blood pressure below 90) or arrhythmia
* patients with altered mental status
* patients with unstable spine/thoracic injury
* patients with recent abdominal surgery
* patients with significant pressure ulcers (above stage 1)
* pregnant patients past the 2nd trimester
* patients that have concerning neurological issues (such as seizures)
* Patients that are unable to change positions independently

Primary outcomes:
measure: Length of stay
timeFrame: 7 months
Secondary outcomes:
measure: Oxygenation
timeFrame: 7 months
measure: Pressure injuries
timeFrame: 7 months
Other outcomes:
measure: demographics
timeFrame: 7 months
Locations:
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
Study officials:
affiliation: Baylor St. Luke's Medical Center
name: Marie Hodges, BSN, RN
role: PRINCIPAL_INVESTIGATOR
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