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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325906
Recruitment Status : Completed
First Posted : March 30, 2020
Results First Posted : February 28, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 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
Actual Primary Completion Date : January 26, 2021
Actual Study Completion Date : February 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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%.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Failure (Intubation or Death) [ Time Frame: 28 days ]
    the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment

  2. Number of Participants With Intubation [ Time Frame: 28 days ]
    intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment

  3. Mortality [ Time Frame: 28 days ]
    mortality of HFNC/HFNC+PP support within 28 days of study enrollment


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 28 days of study enrollment ]
    adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Jie Li, PhD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:
Study Protocol and Informed Consent Form: Informed Consent Form  [PDF] April 1, 2020
Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan  [PDF] September 15, 2020

More Information
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Publications of Results:

Other 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
Results First Posted: February 28, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
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
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
 Infant, Newborn, Diseases
Virus Diseases
Infections
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections