Bioelectric Impedance in Non-invasive Ventilated Patients: The NIVAR Study. (NCT06996197) | Clinical Trial Compass
CompletedNot Applicable
Bioelectric Impedance in Non-invasive Ventilated Patients: The NIVAR Study.
Spain74 participantsStarted 2021-05-12
Plain-language summary
Investigators performed a retrospective observational single-centre study in a cohort of COVID-19 patients with AHRF who required NIV support and intensive care unit (ICU) admission from May 2021 to January 2022. A BIA assessment was performed within the first 24 hours after NIV onset. Patient characteristics, severity scores, HACOR score, NIV settings, and mortality were recorded. Cox-hazard multivariate analysis was used to assess the association between BIA parameters and NIV failure, adjusting for potential covariates.
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:
* Moderate-to-severe Acute Hypoxemic Respiratory Failure (PaO2 /FiO2 \< 200mmHg) due to respiratory infection who underwent NIV support for at least 24h.
Exclusion Criteria:
* Presence of electrical implants, wounds or skin damage at the designated electrode sites or the inability to perform BIA.
* Patients who met criteria for immediate intubation upon ICU admission were also excluded.
* Other circumstances or clinical conditions at the discretion of the investigator that precluded the participation of the patient in the study were also considered (i.e., limitation of therapeutic effort and poor prognosis).
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
NIV failure
Timeframe: through study completion, an average of 1 month.