Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

April 18, 2022 updated by: Lucie Uncapher, Poudre Valley Health System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In hypoxic respiratory failure, placing patients in the prone position improves ventilation to perfusion matching, alveolar recruitment, and alveolar to arterial oxygen gradients. Specifically, in Acute Respiratory Distress Syndrome ARDS, proning intubated patients improves overall mortality. With the emergence of SARS-COV-2, hospitals around the world have seen a marked increase in patients with acute hypoxic respiratory failure and ARDS. This surge in cases has prompted a search for more effective strategies to reduce intubation and improve patient morbidity and mortality. One such strategy is that of voluntary proning, in which awake patients are instructed to prone themselves (Early PP With High Flow Nasal Cannula (HFNC) Versus HFNC in COVID-19 Induced Moderate to Severe ARDS) (COVID-19 smArtphone-based Trial of Non-ICU Admission Prone Positioning (CATNAP)).

This trial proposes a voluntary proning strategy in patients admitted to the hospital, not yet requiring mechanical ventilation. Given the clear evidence that proning improves outcomes in ARDS, investigators hypothesize that early, voluntary self-proning may prevent intubation and improve mortality in patients with SARS-COV-2.

Methods

This is a pilot study of up to 100 participants at UCHealth facilities.

Patients will be assessed if they can self prone safely and be assessed against inclusion and exclusion criteria within 12 hours of admission and randomized to either prone or supine positioning. Baseline labs will be measured and all participants will be monitored continuously via pulse oximetry.

The Standard Supine Control Group will utilize standard oxygen (O2) device in supine position at approximately 30-60 degrees to target peripheral capillary oxygen saturation (SpO2) >90% and the participant or nurse will document time in non-supine position.

The Prone Experimental Group will position patient in approximately 15-degree reverse trendelenburg and prone using pillows for comfort. The participant will be asked to rotate to prone positioning every 2 hours while awake and encourage to sleep prone overnight as possible with a goal of 10-12 hours daily. Patient to log all time prone.

Treatment Failure may occur and termination of Intermittent Prone Positioning will occur. This is defined as respiratory distress or a decrease in O2 saturations <90% for more than 2 minutes as determined by bedside nursing or per virtual pulse oximetry monitoring notifications during the study on two consecutive occasions. The participant will be returned to supine positioning and follow standard supine oxygenation. The participant can be re-challenged in the prone position after the participant stabilizes for 2 hours. The participant can also choose to stop proning and would be considered a treatment failures.

Statistical Analysis and Sample Size In New York City the intubation rate has been reported at 1/3 of COVID-19 positive patients admitted to the hospital. The table below shows the sample size needed for a binomial outcome of intubation when 50% of the sample is randomized to Prone Positioning (PP):

Alpha 0.05 0.05 0.05 0.05 Beta 0.80 0.80 0.80 0.80 Probability of intubation with PP 0.05 0.10 0.15 0.20 Probability of intubation 0.33 0.33 0.33 0.33 Proportion receiving PP 0.50 0.50 0.50 0.50 Sample size 33 39 56 97

Expecting a 13% decrease in intubations with the prone position, investigators will use a sample size of N = 100 (50 per group) in order to have 80% power with a two-sided alpha = 0.05 for logistic regression. ANCOVA will be used to evaluate continuous, secondary variables in order to adjust for covariates. The study is powered for the primary outcome of intubation or no intubation. No adjustments will be made for the secondary endpoints.

The investigators and statistician will validate the data and the study will be subject to institutional quality assurance reviews.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • UCHealth Poudre Valley Hospital
        • Contact:
          • Research Manager
        • Principal Investigator:
          • Lucie Uncapher, MD
      • Greeley, Colorado, United States, 80634
        • Recruiting
        • UCHealth Greeley Hospital
        • Contact:
          • Research Manager
        • Principal Investigator:
          • Lucie Uncapher, MD
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • UCHealth Medical Center of the Rockies
        • Contact:
          • Research Manager
        • Principal Investigator:
          • Lucie Uncapher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prone Positioning
Prone positioning
Other: Prone Positioning
Intervention is patient in prone positioning
Other: Supine Positioning
Other: Supine Positioning
Intervention is patient in supine positioning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of intubation
Time Frame: Through study completion, an average of 6 days
Incidence of intubation
Through study completion, an average of 6 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum oxygen requirement
Time Frame: Through study completion, an average of 6 days
Measure of maximum oxygen requirements
Through study completion, an average of 6 days
Length of Stay
Time Frame: Through study completion, an average of 6 days
Measured in days of hospitalization
Through study completion, an average of 6 days
Ventilator-free days
Time Frame: Through study completion, an average of 6 days
Measured in days not on a ventilator
Through study completion, an average of 6 days
Treatment failure of prone positioning due to worsening SpO2 status while prone
Time Frame: Through study completion, an average of 6 days
Whether or not the participant met treatment failure descriptions
Through study completion, an average of 6 days
Mortality
Time Frame: Through study completion, an average of 6 days
Whether or not the participant died while hospitalized
Through study completion, an average of 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poudre Valley Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lucie Uncapher, University of Colorado Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-6034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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