COVID-19 Clinical Trial
Official title:
Non-ventilated Prone Positioning in the COVID-19 Population
Verified date | July 2023 |
Source | Baylor St. Luke's Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 216 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor St. Luke's Medical Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor St. Luke's Medical Center |
United States,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | demographics | race, ethnicity, height, weight, age, gender | 7 months | |
Primary | Length of stay | amount of time patient was admitted to acute care unit | 7 months | |
Secondary | Oxygenation | Saturation of partial pressure of oxygen (in Litres) | 7 months | |
Secondary | Pressure injuries | presence skin breakdown using clinically accepted wound staging tool | 7 months |
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