Clinical Trials in Brazil / NCT07182851
Recruiting Observational

Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units

NCT07182851 · tracked via the Priya Life Science Brazil tracker
Phase
Observational
Started
2025-06-01
Last updated
2025-09-19

Condition(s) studied

Sedation and AnalgesiaPain Intensity AssessmentMechanical Ventilation Complication

Study summary

Introduction: Pain is a subjective symptom, a physiological response that is difficult to assess, which affects the body physically and/or emotionally. It is a common phenomenon among clinical and surgical patients in Intensive Care Units (ICU). And its effects are the combined results of physiological and behavioral aggressions caused by clinical conditions, immobility and the execution of common procedures in ICU's. The presence of pain appears to be independently associated with worse clinical outcomes, including higher infection rates, patient-ventilator asynchronies, delirium, prolonged mechanical ventilation (MV), length of hospital stay and higher healthcare costs. Objectives: To evaluate the prevalence of pain and its associated factors in mechanically ventilated surgical patients in ICU's. Methods: This is a cohort, prospective, multicenter study designed to estimate the prevalence of pain, its intensity, its associated factors, correlating them to outcomes such as patient-ventilator asynchrony rate, time to weaning, and 28-day mortality in mechanically ventilated patients. All research participants who meet the inclusion criteria and who are not using neuromuscular blockers, or have any other condition associated with altered pain perception, will be evaluated using the Behavioral Pain Scale (BPS) and the Critical Care Pain Observation Tool (CPOT) on the 2nd day of mechanical ventilation and on the first day of awakening, when the RASS scale is between 4 and -2. At the same time, data will be collected on the ongoing sedoanalegesia strategy, and the asynchrony index will be calculated \[(Nº of asynchronous ventilatory cycles/Nº of ventilatory cycles studied) \*100\]. The end point of the research will be 28 days, where the time until weaning, time until discharge or death will be established using the Kaplan-Meier estimators. Expected results: The prevalence of pain and its intensity is associated with the presence of patient-ventilator asynchronies and thus with harsh outcomes related to the length of stay in the ICU, time until weaning and thirty-day mortality in the ICU. It is estimated that there is agreement between the BPS and CPOT scales in mechanically ventilated patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria Participants of both sexes, aged 18 or over; Participants who are using invasive mechanical ventilation, Exclusion Criteria: Participants undergoing treatment with neuromuscular blockers,; Participants with any condition associated with altered pain perception (e.g., Guillain-Barré Syndrome, SCI, etc.); Participants with any condition that would likely interfere with behavioral assessments of pain (e.g., decortication or decerebration posture) As the assessments will be carried out before and after the tracheal aspiration procedure, if the patient does not have objective criteria for tracheal aspiration, he/she will be excluded from the study, irrefutably preventing the procedure from being carried out without express need.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Hospital Central da Aeronáutica Rio de Janeiro Rio de Janeiro Recruiting
Hospital Central da Polícia Militar do Estado do Rio de Janeiro Rio de Janeiro Rio de Janeiro Recruiting
Hospital Universitário Clementino Fraga Filho Rio de Janeiro Rio de Janeiro Recruiting
Hospital Universitário Gafrée Guinle Rio de Janeiro Rio de Janeiro Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07182851 on ClinicalTrials.gov ↗ ← All trials in Brazil