Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Incline Positioning in COVID-19 Patients for Improvement in Oxygen Saturation (UPSAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344561
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting.

The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.


Condition or disease Intervention/treatment Phase
COVID Hypoxic Respiratory Failure Other: Postural Positioning Not Applicable

Detailed Description:

Study Design: The investigators will conduct a pilot study to examine the acute effects of inclined posture on oxyhemoglobin saturation and the feasibility of conducting randomized controlled clinical trial among patients with confirmed or suspected COVID-19-associated hypoxia.

In a subgroup of participants, the investigators will examine the acute effect of postural therapy (15-degree incline on hospital beds) on oxyhemoglobin saturation among hypoxic patients to establish a biologic response. The investigators will enroll a subset of participants (n=16) who will lie supine on hospital beds, which will be placed in the horizontal (flat) or 15-degree inclined (reverse Trendelenberg) orientation in random order. During this time, the investigators will continuous record pulse oximetry, pulse rate and variations in peripheral arterial tone with WatchPAT one devices. Subjects will be visually monitored for work of breathing during this time. If work of breathing becomes excessive, as defined as a sustain respiratory rate of >25 and an increase of >5 breaths per minute from baseline, or oxygenation decreases below 88% for > 30 seconds in the inclined position, then maneuvers will be stopped. If the patient meets these criteria in the flat position, then the investigators sit the patient upright, and allow breathing to return to baseline before examining responses in the inclined position.

The investigators will randomize participants to have beds placed in 15-degree incline or usual care (ad-lib positioning) for 72 hours. During the first night in a subgroup of participants, the investigators will record oxygenation, sleep wake state and markers of sympathetic activity with WatchPAT One devices, which can obtain cardiopulmonary parameters with high temporal resolution. The investigators will obtain vital signs from the data warehouse, which archives telemetry data with a maximum sampling frequency of 1 minute. The investigators will record adherence with continuous accelerometry sensors placed on the bed rails and on the anterolateral surface of participants' chests to measure bed and participants' positions, respectively. Aside from position, participants will receive usual treatment for COVID-19.

The investigators will enroll in 3 phases. At the end of each phase, the investigators will assess for completion of milestones for proceeding to the subsequent phase, as detailed below:

  1. Pilot Study: The investigators will pilot the study in 16 participants to obtain critical information on logistics of conducting the trial including performance of recording instruments in a biocontainment environment, to examine the feasibility of the intervention, perform preliminary safety evaluations to ascertain potential harm and to determine whether the intervention results in a meaningful difference in body position.
  2. Phase II RCT: If inclined therapy results in a difference in body position and no significant safety issues were detected, the investigators will conduct a phase II randomized-controlled trial (RCT) in 70 participants (see sample size calculation below) to estimate the effect size of inclined position on rates of intubation and determine sample size for a Phase III trial.

Randomization will be occur in both phases and will be stratified by study phase and study site.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UPright Incline Positioning in COVID-19 Patients for Oxygen SATuration Improvement With Hypoxemic Respiratory Failure (UPSAT)
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Postural Positioning
Participants in the group will have hospital beds placed in 15 degree (reverse Trendelenburg).
Other: Postural Positioning
Investigators will adjust the positioning of hospital beds to assess improvements in oxygenation and respiratory status.

No Intervention: Standard Care
Participants in this group will have beds managed per standard nursing protocol.



Primary Outcome Measures :
  1. Incidence of Mechanical Ventilation [ Time Frame: 72 hours ]
    Number of participants needing mechanical ventilation over total number of participants per arm.


Secondary Outcome Measures :
  1. Number of participants with supplemental oxygen requirements [ Time Frame: 72 hours ]
    Number of participants with supplemental oxygen requirements.

  2. Mean oxyhemoglobin saturation [ Time Frame: At 24, 48 and 72 hours ]
    Mean oxyhemoglobin saturation (percentage) measured over a 24-hour period.

  3. Mean Nocturnal Oxyhemoglobin Saturation [ Time Frame: Measured between 10pm and 6am daily, up to 72 hours ]
    Mean oxyhemoglobin saturation (percentage) measured over an 8-hour period (between 10pm and 6am).

  4. Heart Rate [ Time Frame: At 10, 24, 48 and 72 hours ]
    Heart Rate (beats per minute) on Routine Vital Sign Assessment.

  5. Respiratory Rate [ Time Frame: At 10, 24, 48 and 72 hours ]
    Respiratory Rate (cycles per minute) on Routine Vital Sign Assessment.

  6. Percentage of time in the assigned position [ Time Frame: 72 hours ]
    Percentage of time participants stay in the assigned position will be used to determine adherence.


Other Outcome Measures:
  1. Acute change in oxyhemoglobin saturation [ Time Frame: During the final 7 minutes at each position, up to 72 hours ]
    Mean oxyhemoglobin saturation (percentage) during final 7 minutes in a position.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 positive
  • Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea).
  • Hypoxemia defined as ≥ 2 L/min oxygen

Exclusion Criteria:

  • Intubation
  • Inability to lie supine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344561


Contacts
Layout table for location contacts
Contact: Luu Pham, MD 410-550-2118 luu.pham@jhmi.edu
Contact: Trishul Siddharthan, MD 410-614-0154 tsiddha1@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Bayview Hospital Recruiting
Baltimore, Maryland, United States, 21224
Contact: Luu Pham, MD    410-550-2118    luu.pham@jhmi.edu   
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Trishul Siddharthan, MD       tsiddha1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Luu Pham, MD Johns Hopkins University
Publications:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04344561    
Other Study ID Numbers: IRB00246834
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to IPD on reasonable request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases