CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 216 enrolled
Drug / intervention
Proning group +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05957588
NCT05957588N/ACompleted

Non-ventilated Prone Positioning in the COVID-19 Population

Baylor St. Luke's Medical Center·interventional·Posted Jul 24, 2023·Updated Jul 24, 2023

In Brief

A clinical study evaluating Proning group and Control group for COVID-19 and 3 related conditions. Completed, enrolled 216 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 24, 2023
Enrollment StartOct 1, 2021
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.9 years ago

Interventions

Proning groupother

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 groupother

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.