Non-ventilated Prone Positioning in the COVID-19 Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Proning Oxygenation Length of Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Proning group

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

Group Type EXPERIMENTAL

Proning group

Intervention Type OTHER

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.

Group Type OTHER

Control group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Hodges, BSN, RN

Role: PRINCIPAL_INVESTIGATOR

Baylor St. Luke's Medical Center

Locations

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Baylor St. Luke's Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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PMID: 33891572 (View on PubMed)

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Provided Documents

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Document Type: Study Protocol

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Document Type: Informed Consent Form

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Study Documents

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Document Type: Informed Consent Form

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.

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Document Type: Study 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.

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