CompletedNot Applicable

Airway Occlusion Measured During Non-invasive Ventilation to Assess Respiratory Effort

Argentina12 participantsStarted 2022-10-30

Plain-language summary

Non-invasive ventilation (NIV) is extensively used in critical care settings and emergency departments for a variety of aetiologies but specially for acute respiratory failure (ARF). It eliminates morbidity related to the endotracheal tube and use of sedatives so it reduces intensive care unit (ICU) complications; however, on the other hand, the harmful effects of spontaneous breathing through the intensity of inspiratory effort may predispose the patient to the onset of self-inflicted lung injury (SILI). Therefore, measuring the level of inspiratory effort is recommended.The aim of this proof-of-concept physiological study was to describe the correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

Who can participate

Age range

18 Years – 60 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: * Healthy subjects over 18 years old who wish to participate were included. Exclusion Criteria: * Exclusion criteria was the presence of any esophageal disease or COPD.

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

correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

Timeframe: The subjects will be measured on each ventilator setting (3 settings) for 10 minutes

Trial details

NCT IDNCT05576246

SponsorClinica Olivos SMG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01

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