Active — Not RecruitingNot Applicable

Early Detection of Acute Respiratory Failure Using an Intelligent Respiratory Monitoring System

Brazil300 participantsStarted 2025-08-18

Plain-language summary

Introduction: The monitoring of respiratory patterns is crucial in the management of respiratory diseases, but in many cases, it still relies on subjective and visual assessment. The use of healthcare technologies based on artificial intelligence (AI) can, in these contexts, enhance clinical decision-making by providing a more objective and accurate analysis. Given the high prevalence of acute and chronic respiratory diseases, the implementation of a device capable of detecting variables such as flow, volume, and time becomes a priority for more effective diagnosis and therapeutic planning. Objective: Evaluate the accuracy, validity, and usability of an intelligent system for monitoring the respiratory pattern of patients at risk of acute respiratory failure. Methods: This is a prospective cohort study that will be conducted in the emergency departments of the Otávio de Freitas Hospital and Urgent Care Units (UPAs). The sample will consist of volunteers of both sexes, aged 18 years or older, breathing spontaneously, and suspected of having acute respiratory failure. Screening will be performed daily, where sociodemographic information, blood gas data, laboratory results, and additional information will be collected. When indicated, pulmonary function tests, respiratory muscle strength tests, and diaphragmatic ultrasound will be conducted. Respiratory pattern data will be collected using the Respiratory Diagnostic Assistant. Statistical analysis will be performed according to data modeling and treatment, adopting significant differences with p \< 0.05. Expected Results: It is expected that the results of this study will provide quantitative data on the respiratory pattern of volunteers suspected of having acute respiratory failure. This information will be integrated into a database with the aim of enhancing the device's ability to detect changes in respiratory patterns, as well as contributing to the development of artificial intelligence capable of accurately and efficiently identifying these changes.

Who can participate

Age range

18 Years – 90 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: * Volunteers and patients of both sexes * Age greater than or equal to 18 years * Spontaneous breathing * Patients awaiting care in emergency departments, urgent care units, and emergency services * Presence of complaints associated with respiratory difficulty * Patients at risk of acute respiratory failure * With or without supplemental oxygen therapy * Ability to remain without oxygen therapy for a minimum period of three minutes Exclusion Criteria: * Psychomotor agitation * Anxiety validated through qualitative assessment * Poor mask fit and/or presence of air leaks * Facial fracture or trauma * Refusal to participate in the study or sign the informed consent form * Contraindications to performing manovacuometry and spirometry, when appropriate, according to the recommendations of the American Thoracic Society and European Respiratory Society (Graham et al., 2019)

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

Respiratory Pattern Assessment using Respiratory Diagnostic Assistant (RDA)

Timeframe: For an average period of four months, until the conclusion of the studies

System Usability Scale

Timeframe: For an average period of four months, until the conclusion of the studies

Trial details

NCT IDNCT07164586

SponsorUniversity of Pernambuco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Patients at Risk of Acute Respiratory Failure trials