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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2021-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Prone Positioning High Flow Nasal Cannula Acute Respiratory Distress Syndrome Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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high flow nasal cannula only

Receive high flow nasal cannula only

Group Type ACTIVE_COMPARATOR

high flow nasal cannula (HFNC)

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

high flow nasal cannula (HFNC)

Intervention Type DEVICE

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)

Intervention Type PROCEDURE

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%.

Interventions

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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.

Intervention Type DEVICE

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%.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No