Early Detection of Acute Respiratory Failure Using an Intelligent Respiratory Monitoring System
Accuracy, Validation, and Usability of an Intelligent Respiratory Pattern Monitoring System in Patients at Risk of Acute Respiratory Failure
1 other identifier
observational
300
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 18, 2025
CompletedFirst Submitted
Initial submission to the registry
August 21, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2025
CompletedSeptember 10, 2025
September 1, 2025
3 months
August 21, 2025
September 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Respiratory Pattern Assessment using Respiratory Diagnostic Assistant (RDA)
The Respiratory Diagnostic Assistant (RDA) is a portable, non-invasive device providing qualitative and quantitative data on respiratory variables. Participants are assessed seated (or supine 30º if needed) through three stages: baseline respiration (3 min), slow vital capacity, and inspiratory capacity maneuvers (3 repetitions each, 1-min intervals). Measured variables include respiratory rate (breaths per minute), mean inspiratory/expiratory flow (L/s), TI (s), TE (s), tidal volumes (mL), minute volumes (L/min). Data are analyzed qualitatively and quantitatively, with graphical representation. Respiratory patterns may be compared with conventional monitoring (pulse oximetry, respiratory rate, or arterial blood gas).
For an average period of four months, until the conclusion of the studies
System Usability Scale
The System Usability Scale (SUS) is a 10-item standardized questionnaire designed to assess usability and user experience of systems. Participants respond on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), generating a total score ranging from 0 to 100. In this study, the SUS will evaluate participants' perceptions of the intelligent respiratory monitoring system, including ease of use, learnability, and satisfaction. The instrument is used solely for data collection and does not constitute a therapeutic intervention."
For an average period of four months, until the conclusion of the studies
Secondary Outcomes (7)
Peak Expiratory Flow (PEF) Data
For an average period of four months, until the conclusion of the studies
Diaphragmatic Excursion Assessment
For an average period of four months, until the conclusion of the studies
Self-reported Dysfunctional Breathing and Hyperventilation Symptoms (Nijmegen Questionnaire)
For an average period of four months, until the conclusion of the studies
Sociodemographic and Clinical Baseline Data Collection (Patient Identification Questionnaire)
Completed once per participant at baseline to collect sociodemographic and basic clinical data
Pulmonary Function Assessment (Spirometry)
For an average period of four months, until the conclusion of the studies
- +2 more secondary outcomes
Other Outcomes (1)
Perceived Respiratory Effort and Breathlessness (Borg Scale)
For an average period of four months, until the conclusion of the studies
Study Arms (2)
Control Group - Healthy Individuals
Individuals without pulmonary impairment as confirmed through comprehensive respiratory assessment including pulmonary function testing (spirometry), respiratory muscle strength evaluation (manometry), and thorough medical history screening for previous respiratory or cardiopulmonary diseases. Participants must demonstrate normal lung function parameters, adequate respiratory muscle strength, and absence of any history of chronic obstructive pulmonary disease, asthma, pneumonia, tuberculosis, or other conditions that could compromise respiratory function
Intervention Group - Patients at Risk of Acute Respiratory Failure
This group will consist of adult patients (≥18 years), of both sexes, seen in emergency departments, urgent care units, or walk-in clinics associated with the study, who are in spontaneous breathing, with or without supplemental oxygen, and present with respiratory complaints associated with the risk of acute respiratory failure. Participants will be assessed using a sociodemographic and clinical form, including their documented medical diagnosis. Respiratory pattern monitoring will be conducted using the Respiratory Diagnostic Assistant (RDA) device, diaphragmatic mobility will be evaluated via ultrasonography, and muscle electrical activity will be assessed through surface electromyography. When clinically appropriate, pulmonary function tests and respiratory muscle strength assessments will also be performed, in accordance with the recommendations of the American Thoracic Society and the European Respiratory Society.
Interventions
Respiratory pattern assessment and continuous monitoring will be conducted utilizing the Respiratory Diagnostic Assistant, a device capable of providing comprehensive quantitative evaluation of respiratory variables including frequency, volume, flow rates, inspiratory/expiratory timing parameters, and respiratory entropy analysis, as well as qualitative analysis of respiratory pattern curves for volume and flow dynamics, incorporating entropy measurements for assessment of respiratory pattern complexity and variability.
Diaphragmatic mobility assessment will be conducted using diaphragmatic ultrasonography, a method capable of providing comprehensive quantitative evaluation of diaphragmatic excursion parameters including range of motion, contraction velocity, muscle thickening during inspiration and expiration, as well as qualitative analysis of diaphragm muscle morphology and echogenicity, incorporating craniocaudal displacement measurements for assessment of contractile function and early detection of diaphragmatic dysfunction."
espiratory muscle electrical activity assessment will be conducted using surface electromyography, a method capable of providing comprehensive quantitative evaluation of muscle activation parameters including electrical signal amplitude, firing frequency, muscle recruitment patterns during inspiration and expiration, as well as qualitative analysis of synchronization and coordination between respiratory muscles, incorporating Root Mean Square (RMS) measurements and spectral analysis for assessment of respiratory neuromuscular function and detection of muscle fatigue.
Respiratory muscle strength assessment will be conducted using manovacuometry, a method capable of providing comprehensive quantitative evaluation of respiratory muscle force parameters including maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), as well as qualitative analysis of contractile capacity and muscle endurance, incorporating peak pressure measurements and performance indices for assessment of global respiratory muscle function and early detection of muscle weakness
Pulmonary function assessment will be conducted using spirometry, a method capable of providing comprehensive quantitative evaluation of respiratory function parameters including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and forced expiratory flow 25-75% (FEF25-75%), as well as qualitative analysis of flow-volume and volume-time curves, incorporating lung capacity and volume measurements for assessment of respiratory mechanics and early detection of obstructive and restrictive ventilatory disorders."
The PowerLab C is a biomedical data acquisition system used as an auxiliary tool for physiological monitoring. In this study, it will be employed to collect respiratory signals and diaphragmatic excursion data through specific sensors, integrated with LabChart software for data visualization and analysis. The device is not considered an investigational intervention, but a supporting tool for data collection.
The Nijmegen Questionnaire is a standardized self-report instrument designed to assess symptoms related to dysfunctional breathing and hyperventilation. In this study, it will be administered to evaluate respiratory symptoms and their impact on participants' daily life. The questionnaire is used solely for data collection and is not considered a therapeutic intervention.
The System Usability Scale (SUS) is a standardized questionnaire used to evaluate the usability and user experience of systems and devices. In this study, it will be applied to assess participants' perceptions of the usability of an intelligent respiratory monitoring system. The SUS will be used solely as a data collection tool and does not constitute a therapeutic intervention.
The Borg Scale is a standardized self-report instrument used to assess perceived exertion and breathlessness during physical activity. In this study, it will be applied to evaluate participants' perception of respiratory effort. The scale is used solely for data collection and is not considered a therapeutic intervention.
The Patient Identification Questionnaire is a standardized form used to collect sociodemographic and basic clinical information from participants, such as age, sex, and medical history. In this study, it will serve solely for data collection and will not constitute a therapeutic intervention.
Peak Expiratory Flow (PEF) measurement is a rapid and noninvasive method to assess the maximum expiratory volume a participant can achieve after a full inhalation. In this study, participants will be seated upright and use a mouthpiece connected to a peak flow meter. After a deep inspiration, they will exhale forcefully, and three measurements will be taken with at least one minute between attempts; the highest value will be recorded. PEF values provide an objective measure of airflow limitation, correlate with asthma symptoms, and will be used solely for data collection, not as a therapeutic intervention
Eligibility Criteria
The population will be composed of healthy participants and patients awaiting care or receiving emergency care in hospital emergency departments and emergency care units affiliated with the study, who are in spontaneous breathing, with or without oxygen therapy, at risk of acute respiratory failure.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Emergency Care Unit from Engenho Velho
Jaboatão dos Guararapes, Pernambuco, 54160-000, Brazil
Department of Physical Therapy
Recife, Pernambuco, 50740-560, Brazil
Otávio de Freitas Hospital
Recife, Pernambuco, 50920-640, Brazil
Related Links
- Development and validation of a respiratory pattern analysis system for Post-COVID-19 patients
- Diagnosis and Epidemiology of Acute Respiratory Failure
- Biomarker-Based Classification of Patients With Acute Respiratory Failure Into Inflammatory Subphenotypes: A Single-Center Exploratory Study
- Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications
- Leveraging intrinsic non-sinusoidal patterns to infer search behavior to predict exposure to respiratory stressors
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 21, 2025
First Posted
September 10, 2025
Study Start
August 18, 2025
Primary Completion
November 28, 2025
Study Completion
December 22, 2025
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Individual participant data (IPD) and supporting documentation will be available starting at the time of publication of the study's main results. Access will remain open or granted upon justified request for at least five years after publication. After this period, continued availability will depend on institutional policies, repository conditions, and the relevance of the dataset for future research.
- Access Criteria
- Access will remain open or granted upon justified request for at least five years after publication.
Individual participant data will be pseudonymized and shared only after publication of the study results through REDCap repositories, with DOI assignment and a Creative Commons license (CC BY-NC-ND). Demographic, clinical, respiratory, and processed datasets supporting the published analyses will be made available, excluding any information that could directly or indirectly identify participants. Access may be open or granted upon justified request, depending on the sensitivity of the data, and any transfers will be governed by formal data use agreements. Data will be curated, version-controlled, and preserved in institutional and secure scientific repositories for at least five years after publication, in strict compliance with the Brazilian General Data Protection Law (LGPD), institutional policies, and all applicable ethical approvals.