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

Active, not recruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

November 28, 2025

Study Completion Date

December 22, 2025

Conditions
Patients at Risk of Acute Respiratory Failure
Interventions
DIAGNOSTIC_TEST

Respiratory Pattern Monitoring

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.

DIAGNOSTIC_TEST

Diaphragmatic Excursion

"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."

DIAGNOSTIC_TEST

Respiratory muscle electrical activity

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.

DIAGNOSTIC_TEST

Respiratory Muscle Strength

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

DIAGNOSTIC_TEST

Pulmonary Function Assessment

"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."

OTHER

Data Acquisition System

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.

OTHER

Nijmegen Questionnaire

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.

OTHER

System Usability Scale (SUS)

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.

OTHER

Borg Scale

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.

OTHER

Patient Identification Questionnaire

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.

DIAGNOSTIC_TEST

Peak Expiratory Flow (PEF) Measurement

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

Trial Locations (3)

54160-000

Emergency Care Unit from Engenho Velho, Jaboatão dos Guararapes

50740-560

Department of Physical Therapy, Recife

50920-640

Otávio de Freitas Hospital, Recife

All Listed Sponsors
collaborator

Fundação de Amparo à Ciência e Tecnologia de Pernambuco

OTHER

collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

lead

University of Pernambuco

OTHER