Trial Outcomes & Findings for Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS (NCT NCT04325906)
NCT ID: NCT04325906
Last Updated: 2022-03-02
Results Overview
intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
28 days
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
High Flow Nasal Cannula Only
Receive 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.
|
HFNC Plus Prone Positioning
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%.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
110
|
112
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
High Flow Nasal Cannula Only
Receive 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.
|
HFNC Plus Prone Positioning
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%.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS
Baseline characteristics by cohort
| Measure |
High Flow Nasal Cannula Only
n=110 Participants
Receive 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.
|
HFNC Plus Prone Positioning
n=112 Participants
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
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 13.3 • n=39 Participants
|
62.2 years
STANDARD_DEVIATION 12.5 • n=41 Participants
|
62.3 years
STANDARD_DEVIATION 12.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=39 Participants
|
40 Participants
n=41 Participants
|
82 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=39 Participants
|
72 Participants
n=41 Participants
|
140 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=39 Participants
|
65 Participants
n=41 Participants
|
122 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 28 daysthe treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Outcome measures
| Measure |
High Flow Nasal Cannula Only
n=110 Participants
Receive 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.
|
HFNC Plus Prone Positioning
n=112 Participants
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%.
|
|---|---|---|
|
Treatment Failure (Intubation or Death)
|
45 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: 28 daysintubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Outcome measures
| Measure |
High Flow Nasal Cannula Only
n=110 Participants
Receive 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.
|
HFNC Plus Prone Positioning
n=112 Participants
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%.
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|---|---|---|
|
Number of Participants With Intubation
|
39 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: 28 daysmortality of HFNC/HFNC+PP support within 28 days of study enrollment
Outcome measures
| Measure |
High Flow Nasal Cannula Only
n=110 Participants
Receive 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.
|
HFNC Plus Prone Positioning
n=112 Participants
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%.
|
|---|---|---|
|
Mortality
|
30 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 28 days of study enrollmentadverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest
Outcome measures
| Measure |
High Flow Nasal Cannula Only
n=110 Participants
Receive 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.
|
HFNC Plus Prone Positioning
n=112 Participants
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%.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
2 Participants
|
Adverse Events
High Flow Nasal Cannula Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 30 deaths
HFNC Plus Prone Positioning
Serious events: 0 serious events
Other events: 2 other events
Deaths: 21 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Flow Nasal Cannula Only
n=110 participants at risk
Receive 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.
|
HFNC Plus Prone Positioning
n=112 participants at risk
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%.
|
|---|---|---|
|
Surgical and medical procedures
Central or arterial line dislodgement
|
0.00%
0/110 • Within 28 days of study enrollment
|
1.8%
2/112 • Number of events 2 • Within 28 days of study enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER