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NCT Number: NCT05957588

Non-ventilated Prone Positioning in the COVID-19 Population

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Length of Stay Lung Diseases Nidovirales Infections Oxygenation Pneumonia Pneumonia, Viral Proning RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proning group

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

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.

Primary outcomes

  1. Length of stay

    Time frame: 7 months

    amount of time patient was admitted to acute care unit

Secondary outcomes

  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 outcomes

  1. demographics

    Time frame: 7 months

    race, ethnicity, height, weight, age, gender

Sponsors and collaborators

Lead sponsor

Baylor St. Luke's Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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