Recruiting

Prone Positioning

Sponsor:

Poudre Valley Health System

Code:

NCT04424797

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prone Positioning

Supine Positioning

Study Details

Brief summary:

A pilot study to investigate the effects of the prone positioning (PP) on hospital patients diagnosed with COVID-19 pneumonia.

Investigators that early self-proning may prevent intubation and improve mortality in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2).

Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will be enrolled to the study.

All participants will be screened and those that meet inclusion and exclusion criteria will be enrolled to one of two groups: one with prone positioning (on the belly) and the other with standard supine positioning (on the back). The patient and nursing staff will monitor times spent in various positions.

Outcome measures include incidence of intubation, max oxygen requirements, length of hospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.

Conditions

COVID-19

Study ID

NCT04424797

Start date

Jul 13, 2020

Status verified date

Apr, 2022

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Jul 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients admitted to the hospital floor with primary diagnosis of confirmed COVID-19 pneumonia and respiratory failure requiring greater than or equal to 2 Liters(L) Nasal Cannula (NC) to maintain SpO2>90%
  • Ability to independently change positions in bed
  • Able to tolerate prone positioning
  • Age greater than 18

Exclusion Criteria:

  • ICU admission on arrival
  • Respiratory distress requiring immediate intubation

  • Respiratory Rate(RR)>35/min, accessory respiratory muscle use (ex. speaking in short sentences), signs of respiratory muscle fatigue, altered mental status, or inability to protect airway
  • Chest or facial trauma, pneumothorax or other contraindication to prone positioning (i.e., spinal instability, recent abdominal surgery, pregnancy, etc)
  • Hemodynamically unstable

  • Heart Rate (HR)>120 bpm, Systolic Blood Pressure (SBP)<90 mmHg, Mean Arterial Pressure (MAP)<65 mmHg or requirement for vasopressor
  • Nausea and vomiting
  • Pregnancy
  • Refusal or inability to tolerate initial prone positioning due to comfort

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prone Positioning

Prone positioning

other: Supine Positioning

Supine Positioning

Interventions

Prone Positioning

Intervention is patient in prone positioning

Supine Positioning

Intervention is patient in supine positioning

Primary outcome measure

  • Incidence of intubation [ Time Frame: Through study completion, an average of 6 days ]

Central Contacts and Locations

Central contacts

Sara Twombly, MACI CCRC

970-297-6188sara.twombly@uchealth.org

Adam Jaskowiak

970-624-1688adam.jaskowiak@uchealth.org

Locations

UCHealth Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Principal Investigator:

Lucie Uncapher, MD

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80634

Principal Investigator:

Lucie Uncapher, MD

UCHealth Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Principal Investigator:

Lucie Uncapher, MD

More Information

Sponsor

Poudre Valley Health System

Last update posted

Apr 25, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Poudre Valley Health System on 2022-04-25.