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

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Status

Completed

Conditions

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

Treatments

Procedure: Prone positioning (PP)
Device: high flow nasal cannula (HFNC)

Study type

Interventional

Funder types

Other

Identifiers

NCT04325906
COVID-19-HFNC+PP

Details and patient eligibility

About

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.

Enrollment

224 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

224 participants in 2 patient groups

high flow nasal cannula only
Active Comparator group
Description:
Receive high flow nasal cannula only
Treatment:
Device: high flow nasal cannula (HFNC)
HFNC plus prone positioning
Experimental group
Description:
Receive high flow nasal cannula plus prone positioning
Treatment:
Procedure: Prone positioning (PP)
Device: high flow nasal cannula (HFNC)

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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