Non-ventilated Prone Positioning in the COVID-19 Population

Sponsor

Baylor St. Luke's Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT05957588

Collaborator

(none)

216

Enrollment

Location

Arms

Actual Duration (Months)

36.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Proning Oxygenation Length of Stay	Other: Proning group Other: Control group	N/A

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

Study Type:

Interventional

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.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 :

Oct 1, 2021

Actual Primary Completion Date :

Apr 1, 2022

Actual Study Completion Date :

Apr 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Length of stay [7 months]
amount of time patient was admitted to acute care unit

Secondary Outcome Measures

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

Other Outcome Measures

demographics [7 months]
race, ethnicity, height, weight, age, gender

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Baylor St. Luke's Medical Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Baylor St. Luke's Medical Center

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

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Publications

Responsible Party:

Baylor St. Luke's Medical Center

ClinicalTrials.gov Identifier:

NCT05957588

Other Study ID Numbers:

BaylorSt.Lukes

First Posted:

Jul 24, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Baylor St. Luke's Medical Center

acute care

self-proning

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 24, 2023