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

Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04325906
Collaborator
(none)
224
Enrollment
1
Location
2
Arms
10.7
Actual Duration (Months)
21
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: high flow nasal cannula (HFNC)
  • Procedure: Prone positioning (PP)
N/A

Study Design

Study Type:
Interventional
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 :
Apr 2, 2020
Actual Primary Completion Date :
Jan 26, 2021
Actual Study Completion Date :
Feb 21, 2021

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Treatment Failure (Intubation or Death) [28 days]

    the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment

  2. Number of Participants With Intubation [28 days]

    intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment

  3. Mortality [28 days]

    mortality of HFNC/HFNC+PP support within 28 days of study enrollment

Secondary Outcome Measures

  1. Number of Participants With Adverse Events [28 days of study enrollment]

    adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Rush University Medical CenterChicagoIllinoisUnited States60612

Sponsors and Collaborators

  • Rush University Medical Center

Investigators

  • Principal Investigator: Jie Li, PhD, Rush University Medical Center

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT04325906
Other Study ID Numbers:
  • COVID-19-HFNC+PP
First Posted:
Mar 30, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.
Period Title: Overall Study
STARTED112112
COMPLETED110112
NOT COMPLETED20

Baseline Characteristics

Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone PositioningTotal
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.Total of all reporting groups
Overall Participants110112222
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
62.5
(13.3)
62.2
(12.5)
62.3
(12.9)
Sex: Female, Male (Count of Participants)
Female
42
38.2%
40
35.7%
82
36.9%
Male
68
61.8%
72
64.3%
140
63.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
57
51.8%
65
58%
122
55%
Not Hispanic or Latino
53
48.2%
47
42%
100
45%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleTreatment Failure (Intubation or Death)
Descriptionthe treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Time Frame28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.
Measure Participants110112
Count of Participants [Participants]
45
40.9%
45
40.2%
2. Primary Outcome
TitleNumber of Participants With Intubation
Descriptionintubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Time Frame28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.
Measure Participants110112
Count of Participants [Participants]
39
35.5%
38
33.9%
3. Primary Outcome
TitleMortality
Descriptionmortality of HFNC/HFNC+PP support within 28 days of study enrollment
Time Frame28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.
Measure Participants110112
Count of Participants [Participants]
30
27.3%
21
18.8%
4. Secondary Outcome
TitleNumber of Participants With Adverse Events
Descriptionadverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest
Time Frame28 days of study enrollment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.
Measure Participants110112
Count of Participants [Participants]
0
0%
2
1.8%

Adverse Events

Time FrameWithin 28 days of study enrollment
Adverse Event Reporting Description
Arm/Group TitleHigh Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Arm/Group DescriptionReceive high flow nasal cannula only 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.Receive high flow nasal cannula plus prone positioning 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. 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%.
All Cause Mortality
High Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total30/110 (27.3%) 21/112 (18.8%)
Serious Adverse Events
High Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/110 (0%) 0/112 (0%)
Other (Not Including Serious) Adverse Events
High Flow Nasal Cannula OnlyHFNC Plus Prone Positioning
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/110 (0%) 2/112 (1.8%)
Surgical and medical procedures
Central or arterial line dislodgement0/110 (0%) 02/112 (1.8%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The study funder (Rice foundation) had no role in study design, data analysis, the preparation or approval of the manuscript, or the decision to submit the manuscript for publication

Results Point of Contact

Name/TitleJie Li, PI
OrganizationRush University
Phone3125634643
Emailjie_li@rush.edu
Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT04325906
Other Study ID Numbers:
  • COVID-19-HFNC+PP
First Posted:
Mar 30, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022