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Non-ventilated Prone Positioning in the COVID-19 Population

Primary Purpose

COVID-19, Proning, Oxygenation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proning group
Control group
Sponsored by
Baylor St. Luke's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring acute care, self-proning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baylor St. Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Proning group

Control group

Arm Description

COVID-19 hypoxemic patients that receive standard of care AND participate in self-proning following the research protocol.

COVID-19 hypoxemic patients that receive standard of care.

Outcomes

Primary Outcome Measures

Length of stay
amount of time patient was admitted to acute care unit

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2023
Last Updated
July 21, 2023
Sponsor
Baylor St. Luke's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05957588
Brief Title
Non-ventilated Prone Positioning in the COVID-19 Population
Official Title
Non-ventilated Prone Positioning in the COVID-19 Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor St. Luke's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Proning, Oxygenation, Length of Stay
Keywords
acute care, self-proning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proning group
Arm Type
Experimental
Arm Description
COVID-19 hypoxemic patients that receive standard of care AND participate in self-proning following the research protocol.
Arm Title
Control group
Arm Type
Other
Arm Description
COVID-19 hypoxemic patients that receive standard of care.
Intervention Type
Other
Intervention Name(s)
Proning group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of stay
Description
amount of time patient was admitted to acute care unit
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Oxygenation
Description
Saturation of partial pressure of oxygen (in Litres)
Time Frame
7 months
Title
Pressure injuries
Description
presence skin breakdown using clinically accepted wound staging tool
Time Frame
7 months
Other Pre-specified Outcome Measures:
Title
demographics
Description
race, ethnicity, height, weight, age, gender
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Hodges, BSN, RN
Organizational Affiliation
Baylor St. Luke's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Links:
URL
http://commonspirit.org
Description
Enterprise login to find out more about research and innovation
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://irbnet.org/release/study/designer.do?ctx_id=9&spk_id=1793612
Available IPD/Information Identifier
Documents
Available IPD/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.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://irbnet.org/release/study/designer.do?ctx_id=9&spk_id=1793612
Available IPD/Information Identifier
Protocol
Available IPD/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.

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Non-ventilated Prone Positioning in the COVID-19 Population

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