CompletedNot Applicable

Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

Chile66 participantsStarted 2020-07-06

Plain-language summary

The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.

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: * Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90% * Treating physician indicated prone position as instructed by the institutional protocol * Patient capable of changing position with minimal help from the personnel Exclusion Criteria: * Patient requiring immediate intubation * Patient requiring non-invasive mechanical ventilation * Respiratory Rate \> 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway * PaCO2 \> 50mmHg * Hemodynamic instability (defined by Heart Rate \> 120, Systolic Pressure \< 90mmHg, Mean Arterial Pressure \< 60mmHg or requiring vasopressor support) * Obesity with BMI \> 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2) * Persistent vomiting * Facial or thoracic trauma or recent surgery contraindicating the prone position * Pregnancy \> 20 weeks

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

Therapeutic failure

Timeframe: At 14 days

Mortality

Timeframe: At day 28

Length of hospital stay

Timeframe: At 28 days

Days requiring high flow nasal oxygen

Timeframe: At 28 days

Days requiring supplemental oxygen

Timeframe: At 28 days

Displacement of invasive devices during position changes

Timeframe: At 28 days

Occurrence of pressure ulcers on the anterior surface of the body

Timeframe: At 28 days

Trial details

NCT IDNCT04641182

SponsorPontificia Universidad Catolica de Chile

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-08-16

View on ClinicalTrials.gov More Covid19 trials

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.

What they're measuring

Therapeutic failure

Timeframe: At 14 days

Mortality

Timeframe: At day 28

Length of hospital stay

Timeframe: At 28 days

Days requiring high flow nasal oxygen

Timeframe: At 28 days

Days requiring supplemental oxygen

Timeframe: At 28 days

Displacement of invasive devices during position changes

Timeframe: At 28 days

Occurrence of pressure ulcers on the anterior surface of the body

Timeframe: At 28 days