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

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ClinicalTrials.gov Identifier: NCT04325906
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prone Positioning High Flow Nasal Cannula Acute Respiratory Distress Syndrome Corona Virus Infection Device: high flow nasal cannula (HFNC) Procedure: Prone positioning (PP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
Actual Study Start Date : April 2, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Active Comparator: high flow nasal cannula only
Receive high flow nasal cannula only
Device: 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.

Experimental: HFNC plus prone positioning
Receive high flow nasal cannula plus prone positioning
Device: 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.

Procedure: 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%.




Primary Outcome Measures :
  1. Treatment failure [ Time Frame: 28 days ]
    the treatment failure rate of HFNC/HFNC+PP support and clinical requirement for advanced respiratory support

  2. Intubation rate [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Efficacy of PP [ Time Frame: 28 days ]
    the improvement of SpO2/FIO2 or PaO2/FiO2 from HFNC alone to HFNC+PP



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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 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

Exclusion Criteria:

  1. 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);
  2. Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change);
  3. unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
  4. unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
  5. chest trauma or any contraindication for PP
  6. pneumothorax
  7. age < 18 years

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): NCT04325906


Contacts
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Contact: Jie Li, PhD 312-947-0065 Jie_Li@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jie Li, PhD    312-947-0065      
Principal Investigator: Sara Mirza, MD         
Principal Investigator: David Vines, PhD         
Principal Investigator: Jie Li, PhD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Jie Li, PhD Rush University Medical Center
Publications:

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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04325906    
Other Study ID Numbers: COVID-19-HFNC+PP
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections