Characteristics and Outcomes of Patients With COVID-19 Treated With HFNO and Prone Positioning (NCT05178212) | Clinical Trial Compass
CompletedNot Applicable
Characteristics and Outcomes of Patients With COVID-19 Treated With HFNO and Prone Positioning
Argentina600 participantsStarted 2020-04-15
Plain-language summary
A subset of patients with COVID-19 develops acute respiratory failure and acute respiratory distress syndrome (ARDS) (1). The use of invasive mechanical ventilation for the treatment of these conditions is associated with high mortality rates (2,3). The use of high-flow nasal oxygen therapy (HFNO) and awake prone position (AW-PP) could to decrease the need for endotracheal intubation and other adverse clinical outcomes (4-6).
The aim of this study is to evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Older than 17 years, admitted to the ICU
* Confirmed diagnosis of COVID-19 (real-time PCR)
* Receiving HFNO for at least 4 hours. Patients received HFNO when any of the following criteria were present: peripheral oxygen saturation (SpO2) \< 92% with oxygen \> 4 liters/minute; increased work of breathing with use of accessory respiratory muscles, and a respiratory rate \> 30/min; PaO2/FiO2ratio \< 200 mmHg.
Exclusion Criteria:
* Patients with respiratory failure secondary to a different etiology,
* Decreased level of consciousness,
* Presence of shock requiring vasopressors,
* Immediate need for intubation.
* Use of positive-pressure ventilation prior to HFNO, and f) with do-not intubate orders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Endotracheal Intubation
Timeframe: Up to 4 weeks
Trial details
NCT IDNCT05178212
SponsorHospital Privado de Comunidad de Mar del Plata