Prone Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome, Corona Virus Infection
Conditions
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.
Interventions
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.
PROCEDUREProne 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%.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure (Intubation or Death) | 28 days | the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment |
| Number of Participants With Intubation | 28 days | intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment |
| Mortality | 28 days | mortality of HFNC/HFNC+PP support within 28 days of study enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 110 |
| 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%. | 112 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | High Flow Nasal Cannula Only | HFNC Plus Prone Positioning | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 13.3 | 62.2 years STANDARD_DEVIATION 12.5 | 62.3 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 57 Participants | 65 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 47 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 42 Participants | 40 Participants | 82 Participants |
| Sex: Female, Male Male | 68 Participants | 72 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 30 / 110 | 21 / 112 |
| other Total, other adverse events | 0 / 110 | 2 / 112 |
| serious Total, serious adverse events | 0 / 110 | 0 / 112 |
Outcome results
Primary
Mortality
mortality of HFNC/HFNC+PP support within 28 days of study enrollment
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Nasal Cannula Only | Mortality | 30 Participants |
| HFNC Plus Prone Positioning | Mortality | 21 Participants |
Primary
Number of Participants With Intubation
intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Nasal Cannula Only | Number of Participants With Intubation | 39 Participants |
| HFNC Plus Prone Positioning | Number of Participants With Intubation | 38 Participants |
Primary
Treatment Failure (Intubation or Death)
the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Nasal Cannula Only | Treatment Failure (Intubation or Death) | 45 Participants |
| HFNC Plus Prone Positioning | Treatment Failure (Intubation or Death) | 45 Participants |
Secondary
Number of Participants With Adverse Events
adverse events include skin breakdown, vomiting, arterial or central line dislodgement, and cardiac arrest
Time frame: 28 days of study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Nasal Cannula Only | Number of Participants With Adverse Events | 0 Participants |
| HFNC Plus Prone Positioning | Number of Participants With Adverse Events | 2 Participants |