Non-ventilated Prone Positioning in the COVID-19 Population

July 21, 2023 updated by: Baylor St. Luke's Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proning group
COVID-19 hypoxemic patients that receive standard of care AND participate in self-proning following the research protocol.
Other: Proning group

Patients were educated about self-proning, and instructed to self-prone every 2 hours. The patient documented their position on the checklists every 2 hours.

Upon initiation of the initial proning, the patient was monitored by the research team RN for adverse effects for 15 minutes (such as inability to tolerate position or signs of respiratory distress).

If the patient tolerated the proning well, the RN entered the patient's oxygen saturation into the EMR, and documented the initial position (prone or supine) on the checklist. O2 saturation was documented at least every 4 hours per unit protocol.

The checklists were placed in a binder at the nurses' station at the end of each shift and collected daily by a member of the research team.

This intervention for each proned patient continued until either of the following occurred: ei the patient was discharged to a lower level of care or 14 days had passed.
Other: Control group
COVID-19 hypoxemic patients that receive standard of care.
Other: Control group
A retrospective chart review was completed by the research team to ascertain length of stay, oxygenation, and pressure injuries for the control group on the acute care, telemetry monitored unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 7 months
amount of time patient was admitted to acute care unit
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: 7 months
Saturation of partial pressure of oxygen (in Litres)
7 months
Pressure injuries
Time Frame: 7 months
presence skin breakdown using clinically accepted wound staging tool
7 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographics
Time Frame: 7 months
race, ethnicity, height, weight, age, gender
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor St. Luke's Medical Center

Investigators

  • Principal Investigator: Marie Hodges, BSN, RN, Baylor St. Luke's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BaylorSt.Lukes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to trial information can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact geraldine.jones@commonspirit.org; marie.hodges@commonspirit.org; and nishant.varghese@commonspirit.org.

IPD Sharing Time Frame

June 2022 - June 2027

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Informed Consent Form
    Information identifier: Documents
    Information comments: This URL and identifier are used internally by Common Spirit Health IRB. The link is IRBNET.org and registration thru CSH is required. The link provides access to a digital document repository including the consent form.
  2. Study Protocol
    Information identifier: Protocol
    Information comments: This URL and identifier are used internally by Common Spirit Health IRB. The link is IRBNET.org and registration thru CSH is required. The link provides access to a digital document repository including the protocol document.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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