Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS
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|ClinicalTrials.gov Identifier: NCT04391140|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : August 18, 2020
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.
Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.
Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.
Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.
Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
|Condition or disease||Intervention/treatment||Phase|
|COVID ARDS Acute Respiratory Distress Syndrome Acute Respiratory Failure Corona Virus Infection||Other: Prone position||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS|
|Actual Study Start Date :||May 13, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Combination of prone position and HFNC
Other: Prone position
HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily.
No Intervention: Control
Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present.
- Therapeutic failure death or intubation [ Time Frame: 28 days within randomization ]Therapeutic failure: death or intubation
- Feasibility and safety of prone position in HFNC patients [ Time Frame: 28 days within randomization ]
- Comfort measurement using a visual-analog scale.
Presence of complications related with prone position and the use of high-flow nasal cannula:
- Skin ulcers.
- Intravascular lines displacement
- HFNC related events (hot air feeling, nasal lesions)
- Efficacy of prone position in HFNC patients [ Time Frame: 28 days within randomization ]
- Evolution of the oxygenation (SpO2/FiO2) in prone position.
- Length of HFNC therapy
- Length of ICU stay
- Length of mechanical ventilation (in those who require intubation)
- ICU and hospital mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391140
|Hospital Universitari Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Oriol Roca, MD PhD +34 93 274 62 09 email@example.com|
|Contact: Marina García-de-Acilu, MD +34 93 274 62 09 firstname.lastname@example.org|
|Sub-Investigator: Oriol Roca, MD PhD|
|Principal Investigator: Marina García-de-Acilu, MD|
|Sub-Investigator: Cesar Laborda, MD|
|Sub-Investigator: Judit Sacanell, MD|
|Sub-Investigator: Jordi Riera, MD PhD|