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

Primary Purpose

Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high flow nasal cannula (HFNC)
Prone positioning (PP)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prone Positioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

high flow nasal cannula only

HFNC plus prone positioning

Arm Description

Receive high flow nasal cannula only

Receive high flow nasal cannula plus prone positioning

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Adverse Events
adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest

Full Information

First Posted
March 26, 2020
Last Updated
February 28, 2022
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04325906
Brief Title
Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS
Official Title
Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
February 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome, Corona Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high flow nasal cannula only
Arm Type
Active Comparator
Arm Description
Receive high flow nasal cannula only
Arm Title
HFNC plus prone positioning
Arm Type
Experimental
Arm Description
Receive high flow nasal cannula plus prone positioning
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula (HFNC)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prone positioning (PP)
Intervention Description
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 Measure Information:
Title
Treatment Failure (Intubation or Death)
Description
the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Time Frame
28 days
Title
Number of Participants With Intubation
Description
intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Time Frame
28 days
Title
Mortality
Description
mortality of HFNC/HFNC+PP support within 28 days of study enrollment
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest
Time Frame
28 days of study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Li, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS

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