Non-ventilated Prone Positioning in the COVID-19 Population

Not Applicable

Completed

• Conditions: Proning; Length of Stay; COVID-19; Oxygenation
• Interventions: Other: Proning group; Other: Control group

• Registration Number: NCT05957588
• Lead Sponsor: Baylor St. Luke's Medical Center

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.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proning group	Proning group	COVID-19 hypoxemic patients that receive standard of care AND participate in self-proning following the research protocol.
Control group	Control group	COVID-19 hypoxemic patients that receive standard of care.

Primary Outcome Measures

Name	Time	Method
Length of stay	7 months	amount of time patient was admitted to acute care unit

Secondary Outcome Measures

Name	Time	Method
Oxygenation	7 months	Saturation of partial pressure of oxygen (in Litres)
Pressure injuries	7 months	presence skin breakdown using clinically accepted wound staging tool

Trial Locations

Locations (1)

Baylor St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States