Prone PositioningNCT04325906

Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS

A study testing high flow nasal cannula (HFNC) and Prone positioning (PP) in people with Prone Positioning and High Flow Nasal Cannula, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome
What is being tested?: high flow nasal cannula (HFNC) and Prone positioning (PP)
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 1 siteUnited States
Study dates: 2 Apr 2020to 21 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

COVID-19 induced adult ARDS patients admitted to the medical ICU
PaO2/FiO2 is less than 200mmHg or FIO2 ≥ 0.4 is required to maintain SpO2 at 88-93% on HFNC treatment

Who cannot join

If the patients have a consistent SpO2<80% when on evaluation with a FiO2 of 0.6, or signs of respiratory fatigue (RR > 40/min, PaCO2> 50mmHg / pH<7.30, and obvious accessory respiratory muscle use);
Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change);
unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
chest trauma or any contraindication for PP
pneumothorax
age < 18 years

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.

Conditions: Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome, Corona Virus Infection
Being tested: high flow nasal cannula (HFNC), Prone positioning (PP)
Medical subject headings: Respiratory Distress Syndrome, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high flow nasal cannula (HFNC)Device
HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher \&Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.
Prone positioning (PP)Procedure or surgery
PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%.

Study groups in NCT04325906
Study group	Role	What they receive
high flow nasal cannula only	Active comparator	Receive high flow nasal cannula only Receives: Device: high flow nasal cannula (HFNC)
HFNC plus prone positioning	Experimental	Receive high flow nasal cannula plus prone positioning Receives: Device: high flow nasal cannula (HFNC); Procedure: Prone positioning (PP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Failure (Intubation or Death)
the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Measured: 28 days
Number of Participants With Intubation
intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Measured: 28 days
Mortality
mortality of HFNC/HFNC+PP support within 28 days of study enrollment
Measured: 28 days

Secondary outcomes (1)

Number of Participants With Adverse Events
adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest
Measured: 28 days of study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202021 Feb 2021

First posted30 Mar 2020
Study start2 Apr 2020
Primary completion26 Jan 2021
Study completion21 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Prone PositioningStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04325906
Sponsor's protocol ID: COVID-19-HFNC+PP
Status last verified: Feb 2022
First submitted: 26 Mar 2020
Last updated: 2 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PubMed 23688302
Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
PubMed 32000806
Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.
PubMed 29068269
Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
PubMed 27400909
Respiratory care committee of Chinese Thoracic Society. [Expert consensus on preventing nosocomial transmission during respiratory care for critically ill patients infected by 2019 novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Feb 20;17(0):E020. doi: 10.3760/cma.j.issn.1001-0939.2020.0020. Online ahead of print. Chinese.
PubMed 32077661
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908
Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
PubMed 33177145
Pavlov I, He H, McNicholas B, Perez Y, Tavernier E, Trump MW, Jackson JA, Zhang W, Rubin DS, Spiegel T, Hung A, Estrada MAI, Roca O, Vines DL, Cosgrave D, Mirza S, Laffey JG, Rice TW, Ehrmann S, Li J. Awake Prone Positioning in Non-Intubated Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19. Respir Care. 2022 Jan;67(1):102-114. doi: 10.4187/respcare.09191. Epub 2021 Jul 7.
PubMed 34234032
Li J, Pavlov I, Laffey JG, Roca O, Mirza S, Perez Y, McNicholas B, Cosgrave D, Vines D, Tavernier E, Ehrmann S. Meta-trial of awake prone positioning with nasal high flow therapy: Invitation to join a pandemic collaborative research effort. J Crit Care. 2020 Dec;60:140-142. doi: 10.1016/j.jcrc.2020.07.020. Epub 2020 Jul 24. No abstract available.
PubMed 32799184
Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
PubMed 34425070
Kaur R, Vines DL, Mirza S, Elshafei A, Jackson JA, Harnois LJ, Weiss T, Scott JB, Trump MW, Mogri I, Cerda F, Alolaiwat AA, Miller AR, Klein AM, Oetting TW, Morris L, Heckart S, Capouch L, He H, Li J. Early versus late awake prone positioning in non-intubated patients with COVID-19. Crit Care. 2021 Sep 17;25(1):340. doi: 10.1186/s13054-021-03761-9.
PubMed 34535158

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Active, not recruiting
Core Muscle Activation With Pelvic Neutral Positioning in Division I Soccer Athletes
Core Muscle Activation
Not yet recruiting
Improving Combined PET/CT and MRI of the Breast Using Dedicated Breast Positioning and Image Registration
Breast Cancer, Breast - Female

All Prone Positioning trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
ClinicalTrials.gov ID: NCT04325906
Acronym / sponsor ID: COVID-19-HFNC+PP
Conditions: Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome, Corona Virus Infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: 2 Apr 2020 (actual)
Primary completion: 26 Jan 2021 (actual)
Study completion: 21 Feb 2021 (actual)
First posted: 30 Mar 2020 (actual)
Results: Posted 28 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
high flow nasal cannula only	Active comparator	Device: high flow nasal cannula (HFNC)Receive high flow nasal cannula only
HFNC plus prone positioning	Experimental	Device: high flow nasal cannula (HFNC), Procedure: Prone positioning (PP)Receive high flow nasal cannula plus prone positioning

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

COVID-19 induced adult ARDS patients admitted to the medical ICU
PaO2/FiO2 is less than 200mmHg or FIO2 ≥ 0.4 is required to maintain SpO2 at 88-93% on HFNC treatment

Key exclusion criteria (7 listed)

If the patients have a consistent SpO2<80% when on evaluation with a FiO2 of 0.6, or signs of respiratory fatigue (RR > 40/min, PaCO2> 50mmHg / pH<7.30, and obvious accessory respiratory muscle use);
Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change);
unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
chest trauma or any contraindication for PP

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high flow nasal cannula (HFNC)HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher \&Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.	Device	HFNC plus prone positioning, high flow nasal cannula only
Prone positioning (PP)PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%.	Procedure or surgery	HFNC plus prone positioning

Primary outcome

Treatment Failure (Intubation or Death)
Time frame: 28 days
the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Number of Participants With Intubation
Time frame: 28 days
intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Mortality
Time frame: 28 days
mortality of HFNC/HFNC+PP support within 28 days of study enrollment

1 secondary outcome

Number of Participants With Adverse Events
Time frame: 28 days of study enrollment

Results and safety

Results posted to the registry on 28 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Flow Nasal Cannula Only	112	110
HFNC Plus Prone Positioning	112	112

Primary outcome: Treatment Failure (Intubation or Death)

Time frame: 28 days. Count of participants. Unit: Participants

Measure	High Flow Nasal Cannula Only n = 110	HFNC Plus Prone Positioning n = 112
Value	45	45

Primary outcome: Number of Participants With Intubation

Time frame: 28 days. Count of participants. Unit: Participants

Measure	High Flow Nasal Cannula Only n = 110	HFNC Plus Prone Positioning n = 112
Value	39	38

Primary outcome: Mortality

Time frame: 28 days. Count of participants. Unit: Participants

Measure	High Flow Nasal Cannula Only n = 110	HFNC Plus Prone Positioning n = 112
Value	30	21

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Within 28 days of study enrollment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Flow Nasal Cannula Only	0 of 110 (0%)	0 of 110 (0%)	30 of 110
HFNC Plus Prone Positioning	0 of 112 (0%)	2 of 112 (1.8%)	21 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23688302Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
Background: PubMed 32000806Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
Background: PubMed 29068269Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.
Background: PubMed 27400909Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
Background: PubMed 32077661Respiratory care committee of Chinese Thoracic Society. [Expert consensus on preventing nosocomial transmission during respiratory care for critically ill patients infected by 2019 novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Feb 20;17(0):E020. doi: 10.3760/cma.j.issn.1001-0939.2020.0020. Online ahead of print. Chinese.
Background: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Background: PubMed 33177145Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
Background: PubMed 34234032Pavlov I, He H, McNicholas B, Perez Y, Tavernier E, Trump MW, Jackson JA, Zhang W, Rubin DS, Spiegel T, Hung A, Estrada MAI, Roca O, Vines DL, Cosgrave D, Mirza S, Laffey JG, Rice TW, Ehrmann S, Li J. Awake Prone Positioning in Non-Intubated Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19. Respir Care. 2022 Jan;67(1):102-114. doi: 10.4187/respcare.09191. Epub 2021 Jul 7.
Background: PubMed 32799184Li J, Pavlov I, Laffey JG, Roca O, Mirza S, Perez Y, McNicholas B, Cosgrave D, Vines D, Tavernier E, Ehrmann S. Meta-trial of awake prone positioning with nasal high flow therapy: Invitation to join a pandemic collaborative research effort. J Crit Care. 2020 Dec;60:140-142. doi: 10.1016/j.jcrc.2020.07.020. Epub 2020 Jul 24. No abstract available.
Results publication: PubMed 34425070Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
Results publication: PubMed 34535158Kaur R, Vines DL, Mirza S, Elshafei A, Jackson JA, Harnois LJ, Weiss T, Scott JB, Trump MW, Mogri I, Cerda F, Alolaiwat AA, Miller AR, Klein AM, Oetting TW, Morris L, Heckart S, Capouch L, He H, Li J. Early versus late awake prone positioning in non-intubated patients with COVID-19. Crit Care. 2021 Sep 17;25(1):340. doi: 10.1186/s13054-021-03761-9.
Individual participant dataSharing planned: No

Related trials for Prone Positioning

Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Active, not recruiting
Core Muscle Activation With Pelvic Neutral Positioning in Division I Soccer Athletes
Core Muscle Activation
Not yet recruiting
Improving Combined PET/CT and MRI of the Breast Using Dedicated Breast Positioning and Image Registration
Breast Cancer, Breast - Female

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jie Li, PhD principal investigator

Rush University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Failure (Intubation or Death) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325906, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.