Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Last Update Posted : April 23, 2021
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 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


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 (intubation or death) [ Time Frame: 28 days ]
    the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment

  2. Intubation rate [ 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. Efficacy of PP [ Time Frame: 28 days ]
    the improvement of SpO2/FIO2 or PaO2/FiO2 from HFNC alone to HFNC+PP within 28 days of study enrollment

  2. the incidence of adverse events [ Time Frame: 28 days ]
    the incidence of adverse events, including vomiting, line/tube dislodgement, and desaturation during PP within 28 days of study enrollment



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 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


Locations
Layout table for location information
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jie Li, PhD Rush University Medical Center
Publications:

Layout table for additonal information
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 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
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