Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units

NCT07182851 | Recruiting DMC

• 1 other identifier: pain_icu_unisuam_2025
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Sedation and Analgesia; Pain Intensity Assessment; Mechanical Ventilation Complication

Keywords

mechanical ventilation; intensive care unit; Pain Assessment

Outcome Measures

Primary Outcomes (2)

• Pain Intensity by BPS

  The intensity of pain will be assessment by Behavioral Pain Scale (BPS) in the morning, after the first tracheal suctioning procedure.

  From second day after enrollment , from first day at RASS -2 or minus, with end point 28 - day.

• Pain intensity by CPOT

  The intensity of pain will be assessment by Critical care pain observation tool (CPOT) in the morning after the first tracheal suctioning procedure.

  Time Frame: From second day after enrollment , from first day at RASS -2 or minus, with end point 28 - day.

Secondary Outcomes (6)

• Ventilatory Settings

  From second day after enrollment, from first day at RASS-2 or minus, with end point 28-day"

• Airway occlusion pressure(P0.1)

  This measurement will be taken on the second day of mechanical ventilation and on the first day after reduction or suspension of sedation in which the patient assumes a RASS -2 or less. The study endpoint will be in 28 days.

• Patient-mechanical ventilator asynchrony index

  This asynchrony index will be measured on the second day of mechanical ventilation and on the first day after suspension or reduction of sedation with the participant assuming a RASS-2 or less. The study endpoint will be 28 days.

• 28-day mortality

  28 days

• Duration of mechanical ventilation

  Up to 28 days or hospital discharge, whichever occurs first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patientes admitted in ICU's in use of invasive mechanical ventilation

You may qualify if:

• Participants of both sexes, aged 18 or over;
• Participants who are using invasive mechanical ventilation,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Hospital Central da Aeronáutica, Rio de Janeiro: collaborator
• Hospital Universitário Clementino Fraga Filho: collaborator
• Hospital Universitário Gafrée Guinle: collaborator
• Hospital Central da Polícia Militar do Estado do Rio de Janeiro: collaborator
• Hospital Doutor João Felício: collaborator

Study Sites (4)

Hospital Central da Aeronáutica

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Hospital Central da Polícia Militar do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Hospital Universitário Gafrée Guinle

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arthur S Ferreira, Dsc

CONTACT

+552238829797; asferreira@unisuam.edu.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: September 19, 2025
• Study Start: June 1, 2025
• Primary Completion: December 20, 2025
• Study Completion: March 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From december 2025 for 5 five years

Locations

BR (4)