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Completed

NCT Number: NCT04325906

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

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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Key information

Conditions

Prone Positioning Acute Respiratory Distress Syndrome Corona Virus Infection Coronaviridae Infections Coronavirus Infections High Flow Nasal Cannula Infections Lung Diseases Nidovirales Infections RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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);
  • Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change);
  • unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
  • unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
  • chest trauma or any contraindication for PP
  • pneumothorax
  • age < 18 years

Treatment and study plan

High flow nasal cannula (HFNC)

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)

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%.

Primary outcomes

  1. Treatment Failure (Intubation or Death)

    Time frame: 28 days

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

  2. Number of Participants With Intubation

    Time frame: 28 days

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

  3. Mortality

    Time frame: 28 days

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

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 28 days of study enrollment

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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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