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Non-ventilated Prone Positioning in the COVID-19 Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05957588
Recruitment Status : Completed
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
Sponsor:
Information provided by (Responsible Party):
Baylor St. Luke's Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Proning Oxygenation Length of Stay Other: Proning group Other: Control group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non-ventilated Prone Positioning in the COVID-19 Population
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Length of stay [ Time Frame: 7 months ]
    amount of time patient was admitted to acute care unit


Secondary Outcome Measures :
  1. Oxygenation [ Time Frame: 7 months ]
    Saturation of partial pressure of oxygen (in Litres)

  2. Pressure injuries [ Time Frame: 7 months ]
    presence skin breakdown using clinically accepted wound staging tool


Other Outcome Measures:
  1. demographics [ Time Frame: 7 months ]
    race, ethnicity, height, weight, age, gender


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05957588


Locations
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United States, Texas
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor St. Luke's Medical Center
Investigators
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Principal Investigator: Marie Hodges, BSN, RN Baylor St. Luke's Medical Center
  Study Documents (Full-Text)

Documents provided by Baylor St. Luke's Medical Center:
Study Protocol  [PDF] June 7, 2023
Informed Consent Form  [PDF] June 7, 2023

More Information
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Additional Information:

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: Documents
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.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Protocol
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.

Publications:
World Health Organization (WHO). (2020). Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected: Interim guidance. World Health Organization, 1-10. https://www.who.int/publications/i/item/10665-332299

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Responsible Party: Baylor St. Luke's Medical Center
ClinicalTrials.gov Identifier: NCT05957588    
Other Study ID Numbers: BaylorSt.Lukes
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: July 24, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: June 2022 - June 2027

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor St. Luke's Medical Center:
acute care
self-proning
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases