Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
Phase: NA
Conditions: Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome, Corona Virus Infection
Sponsor: Rush University Medical Center

Rush Template Version Date: 11/12/2019
Consent/Authorization Version Date: 03/31/2020
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CONSENT/AUTHORIZATION FOR PARTICIPATION IN A RESEARCH 
STUDY
Site Principal Investigator:
Jie Li, PhD, RRT, RRT-ACCS, RRT-NPS
Department:
Department of Cardiopulmonary Sciences, Division of 
Respiratory Care
Address and Contact Information: 1620 W Harrison St, Tower LL1202, Chicago, IL. 60612. 
Jie_Li@rush.edu; 312-947-0065
Protocol Title:
A Multicenter Randomized Controlled Trial of Early Use 
of Prone Positioning Combined with HFNC in COVID-19 
Induced Moderate to severe Acute Respiratory Distress 
Syndrome
Name of Participant:  __________________________________________________________
Key Information:
You are being invited to participate in a research study. Research studies answer important 
questions that might help change or improve the way we do things in the future.
This consent form will give you information about the study to help you decide whether you 
want to participate. Please read this form, and ask any questions you have, before agreeing to be 
in the study.
Taking part in this research study is voluntary. You do not have to participate in this study and 
may choose to leave the study at any time. If you decide not to participate in this study or leave 
the study at a later time, your health care, benefits, or relationship with Rush University Medical 
Center will not change or be affected.
The purpose of this study is to investigate if early use of prone positioning combined with high-
flow nasal cannula (HFNC) could improve oxygenation and ultimately avoid intubation in 
COVID-19 induced moderate to severe Acute Respiratory Distress Syndrome patients.
If you agree to participate in this study, your participation may last up to four weeks.
During these visits, you will be change your position to prone if you are randomized to prone 
position group. 
There are risks to you for participating in this study. In this study, there is a risk of deterioration 
of hypoxia when you are turning to the prone position, but clinicians will monitor your saturation 
and titrate oxygen to meet your need to prevent hypoxemia. You may also have skin breakdown 
ORA: 20032604-IRB01   Date IRB Approved: 4/1/2020

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during prone position, but your comfort will be checked by clinicians every 30 minutes, you are 
allowed to turn back to supine position any time you feel any discomfort. 
You may benefit from taking part in this study. Based on experience with HFNC and prone 
positioning in patients with similar conditions, researchers believe it may be of benefit to people 
with your condition. However, because individuals respond differently to therapy, no one can 
know in advance if it will be helpful for you.
You have the option to not participate in this study.
Detailed Information: Please review the rest of this document for details about 
the above topics and additional information you should know before making a 
decision about whether or not you will participate in this study.
Why are you being invited to participate in this study?
You are being asked to participate in this study because you are diagnosed as COVID-19 
induced moderate to severe Acute Respiratory Distress Syndrome.
How many participants will take part in this study?
Approximately 350 participants are expected to take part in this study. And 120 participants are 
expected to take part in the study at Rush.
What are the activities you will be doing if you participate in this study?
If you agree to be in this study, you will be asked to participate in the following activities: 
During the Screening Period 

You will receive high-flow nasal cannula oxygen therapy for 30 minutes to measure your 
oxygenation.
During the Treatment Period

You will be randomized to continue using high-flow nasal cannula oxygen therapy, or 
prone position with high-flow nasal cannula oxygen therapy. 

If you assigned to the treatment of prone position with high-flow nasal cannula oxygen 
therapy, you will turn the position to prone by yourself at your pace, clinicians will stay 
bedside with you during the position change, oxygen flow will be adjusted based on your 
response to prone position. During prone position therapy, you still need to wear high-
flow nasal cannula oxygen therapy. You will turn from supine to prone position for at 
least 30 minutes twice a day.
What are the risks and discomforts of participating in this study?
Side effects, risks, and/or discomforts from participation in this study may include:

In this study, there is a risk of deterioration of hypoxia when you are being turned to the 
prone position, but precautions will be taken to prevent this from happening.

When you received high flow nasal cannula treatment, you may feel discomfort for the 
hot humidified oxygen flow, and we will adjust the temperature for you. 
ORA: 20032604-IRB01   Date IRB Approved: 4/1/2020

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What if there is new information that may affect your decision to participate in this study?
During this study, you will be told about important findings (either good or bad), such as changes 
in the risks or benefits of participation in the study or new choices to participation that might 
cause you to change your mind about being in the study. If new information is shared with you, 
you may be asked to sign a revised consent form in order to continue participating in this study.
Will you receive your individual results from the study?
Generally, activities performed for research purposes are not meant to provide clinical 
information. We may learn things about you from this study which could be important to your 
health or treatment. If this happens, this information will be shared with you. You will know how 
your response to the treatment after you received the high-flow nasal cannula oxygen therapy or 
high-flow nasal cannula oxygen therapy plus prone positioning.
Can you leave or be removed from this study?
You have the right to leave a study at any time without penalty. For your safety, however, you 
should consider the study doctor’s advice about how to leave this study. If you leave this study 
before the final study visit, the study doctor may ask you to complete the final steps. You will 
receive the standard care if you decided to withdraw from the research.
The researchers and Sponsor also have the right to stop your participation in this study without 
your consent if:

They believe it is in your best interests;

You do not follow the instructions;

The study is cancelled for any reason.
What about confidentiality of your medical information?
This authorization is voluntary. Rush University Medical Center and its affiliates (“Rush”) will 
not withhold or refuse your treatment, payment, enrollment, or eligibility for benefits if you do 
not sign this authorization. You do not have to sign this authorization, but that means that you 
cannot be in the study or receive study-related treatment.
By signing this document, you voluntarily authorize (give permission to) Dr. Li, her study team, 
and other Rush personnel involved with the conduct and review of this study (which may include 
off-site personnel) to use or disclose (release) health information that identifies you for the study 
described in this document.
During the study, Dr. Li and her study team will collect Protected Health Information (PHI) 
about you for the purposes of this research. PHI is your health information that includes your 
medical history and new information obtained as a result of this study. Some of this information 
will come from your medical record. The health information that Rush may use or disclose for 
this research includes:

Your demographic information, including age, gender, medical history, diagnosis for 
COVID-19;

The laboratory and microbiology findings, treatment and outcome. 
ORA: 20032604-IRB01   Date IRB Approved: 4/1/2020

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
Complications including skin breakdown, IV line or nasal cannula dislodgement or 
desaturation during position change. 

The respiratory assessments before, during the treatments of high-flow nasal cannula 
oxygen therapy or high-flow nasal cannula oxygen therapy plus prone positioning.
Dr. Li and her study team may share your health information and the results of your study-
related procedures and tests with people outside of Rush who assist with the conduct and review 
of this study. The persons who receive your health information may not be required by Federal 
privacy laws to protect it and may share your information with others without your permission, 
but only if permitted by the laws governing them. Your health information described above may 
be used or disclosed to:

Monitoring agencies such as the Food and Drug Administration (FDA), the National 
Institutes of Health and the Rush Institutional Review Board (IRB).
While you participate in the study you will have access to your medical record, but Dr. Li is not 
required to release to you study information that is not part of your medical record. Rush is 
required by law to protect your health information, and study records that identify you will be 
kept confidential. The results of study tests/procedures performed as part of this study may 
become part of your medical record. Any study information in your medical record will be kept 
indefinitely. Your identity will not be revealed on any report, publication, or at scientific 
meetings. 
You have a right to inspect and copy the information to be disclosed with this authorization and 
you may obtain a copy of the information by contacting the office listed below.
If you no longer want to be in the study and do not want your future health information to be 
used, you may change your mind and revoke (take back) this authorization at any time by writing 
to Dr. Li at 1620 W Harrison St, Tower LL1202, Chicago, IL. 60612. If the authorization is 
revoked, you will no longer be allowed to participate in the study and previously authorized 
individuals/entities may still use or disclose health information that they have already obtained 
about you as necessary to maintain the integrity or reliability of the current study.
This authorization is valid for the entirety of this research study. It will expire upon completion 
of the study or if you revoke (take back) the authorization.
If you withdraw from this study, the data already collected from you may not be removed from 
the study records. The study doctor and/or study team may ask you whether they can continue to 
collect follow-up data on you. If follow-up information will be requested, you will be asked to 
sign a separate consent form before this information can be collected.
Records of participation in this study will be maintained and kept confidential as required by 
law. We will use coded names or identification numbers, removal of all identifying information.
The Rush Institutional Review Board (IRB) will have access to your files as they pertain to this 
research study. The IRB is a special committee that reviews new and ongoing human research 
ORA: 20032604-IRB01   Date IRB Approved: 4/1/2020

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studies to check that the rules and regulations are followed regarding the protection of the rights 
and welfare of human participants.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. This 
research study can be found by searching for the following Clinical Trial Registry Number 
(NCT#): 04325906.
What are the costs to participate in this study?
There are no costs to you for participating in this research. 
Will you be paid for your participation in this study?
You will not be paid for being in this study.
SIGNATURE BY THE PARTICIPANT:
By signing below, you are consenting to participate in this research study. You have read the 
information given or someone has read it to you. You have had the opportunity to ask questions, 
which have been answered satisfactorily to you by the study staff. You do not waive any of your 
legal rights by signing this consent/authorization form. You will be given a signed copy of this 
document.
_________________________________
_______________________ __________________
Name of Participant
Signature of Participant
Date of Signature
______________________________________________________________________________
Minor Assent
Date of Signature
______________________________________________________________________________
Parent, Guardian or Legal Representative’s Signature
Date of Signature
SIGNATURE BY THE INVESTIGATOR/INDIVIDUAL OBTAINING CONSENT:
I attest that all the elements of informed consent described in this consent document have been 
discussed fully in non-technical terms with the participant. I further attest that all questions asked 
by the participant were answered to the best of my knowledge.
_______________________________________________________
__________________
Signature of Individual Obtaining Consent
Date of Signature
ORA: 20032604-IRB01   Date IRB Approved: 4/1/2020