NCT04424797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 13, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

June 5, 2020

Last Update Submit

April 18, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Incidence of intubation

    Incidence of intubation

    Through study completion, an average of 6 days

Secondary Outcomes (5)

  • Maximum oxygen requirement

    Through study completion, an average of 6 days

  • Length of Stay

    Through study completion, an average of 6 days

  • Ventilator-free days

    Through study completion, an average of 6 days

  • Treatment failure of prone positioning due to worsening SpO2 status while prone

    Through study completion, an average of 6 days

  • Mortality

    Through study completion, an average of 6 days

Study Arms (2)

Prone Positioning

EXPERIMENTAL

Prone positioning

Other: Prone Positioning

Supine Positioning

OTHER

Supine Positioning

Other: Supine Positioning

Interventions

Prone PositioningOTHER

Intervention is patient in prone positioning

Prone Positioning
Supine PositioningOTHER

Intervention is patient in supine positioning

Supine Positioning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80634, United States

RECRUITING

UCHealth Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lucie Uncapher

    University of Colorado Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Twombly, MACI CCRC

CONTACT

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

Adam Jaskowiak

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prone vs. Supine positioning
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 11, 2020

Study Start

July 13, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)