An interventional study of Proning group and Control group in COVID-19, Proning and Oxygenation, sponsored by Baylor St. Luke's Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Baylor St. Luke's Medical Center · Not applicable, Interventional, and Prevention
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.
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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 216 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Baylor St. Luke's Medical Center as lead sponsor.
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Exclusion Criteria:
COVID-19 hypoxemic patients that receive standard of care AND participate in self-proning following the research protocol.
Other: Proning group
COVID-19 hypoxemic patients that receive standard of care.
Other: Control 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.
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.
Length of stay
amount of time patient was admitted to acute care unit
Time frame: 7 months
Oxygenation
Saturation of partial pressure of oxygen (in Litres)
Time frame: 7 months
Pressure injuries
presence skin breakdown using clinically accepted wound staging tool
Time frame: 7 months
demographics
race, ethnicity, height, weight, age, gender
Time frame: 7 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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 information: Study protocol, Informed consent form
Time frame: June 2022 - June 2027
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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