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

Not Applicable

Completed

• Conditions: Prone Positioning; Corona Virus Infection; High Flow Nasal Cannula; Acute Respiratory Distress Syndrome
• Interventions: Device: high flow nasal cannula (HFNC); Procedure: Prone positioning (PP)

• Registration Number: NCT04325906
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Study Start: 2020-04-02
• Primary Completion: 2021-01-26
• Study Completion: 2021-02-21
• Status Verified: 2022-02
• Results First Submitted: 2022-02-02
• Results First Submitted QC: 2022-02-24
• Results First Posted: 2022-02-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC plus prone positioning	high flow nasal cannula (HFNC)	Receive high flow nasal cannula plus prone positioning
high flow nasal cannula only	high flow nasal cannula (HFNC)	Receive high flow nasal cannula only
HFNC plus prone positioning	Prone positioning (PP)	Receive high flow nasal cannula plus prone positioning

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States