CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 224 enrolled
Drug / intervention
high flow nasal cannula (HFNC) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04325906
NCT04325906N/ACompleted

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

Rush University Medical Center·interventional·Posted Mar 30, 2020·Updated Mar 2, 2022

In Brief

A clinical study evaluating high flow nasal cannula (HFNC) and Prone positioning (PP) for Prone Positioning and 3 related conditions. Completed, enrolled 224 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 30, 2020
Enrollment StartApr 2, 2020
Primary CompletionJan 26, 2021
Study CompletionFeb 21, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.3 years ago

Interventions

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%.