Actively Recruiting
Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units
Led by Centro Universitário Augusto Motta · Updated on 2025-09-19
370
Participants Needed
4
Research Sites
14 weeks
Total Duration
On this page
Sponsors
C
Centro Universitário Augusto Motta
Lead Sponsor
H
Hospital Central da Aeronáutica, Rio de Janeiro
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how common pain is and its related factors in patients who are on mechanical ventilators in Intensive Care Units (ICUs), especially after surgery. Pain in these patients is challenging to assess and can affect their physical and emotional well-being. The study will explore how pain connects with patient-ventilator asynchrony, time to weaning off ventilation, length of ICU stay, and 28-day mortality. It is a prospective, multicenter observational study involving multiple hospitals. Participants will be assessed at two key times: the second day after starting mechanical ventilation and the first day after sedation is reduced or stopped. Pain will be measured using two validated tools, the Behavioral Pain Scale (BPS) and the Critical Care Pain Observation Tool (CPOT). Alongside pain assessment, ventilator settings, sedation and analgesia details, and the patient-ventilator asynchrony index will be recorded. Data collection will be standardized and coordinated across centers, with trained researchers entering information into a secure database. During the study, patient data such as age, sex, surgery type, and clinical scores will be collected. Researchers will evaluate pain intensity before and after routine tracheal suctioning, a known painful procedure, and track outcomes including time to successful weaning from ventilation, ICU discharge, and 28-day mortality. Statistical analyses will identify factors linked to pain and its impact on clinical outcomes. The total study duration will follow patients up to 28 days after enrollment.
CONDITIONS
Brief Title
Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of both sexes, aged 18 or over
- Participants who are using invasive mechanical ventilation
You will not qualify if you...
- Participants undergoing treatment with neuromuscular blockers
- Participants with any condition associated with altered pain perception, such as Guillain-Barré Syndrome or spinal cord injury
- Participants with conditions likely to interfere with behavioral pain assessments, such as decortication or decerebration posture
- Participants without objective criteria for tracheal aspiration when assessment is needed, preventing the procedure from being performed without clear need or consent, will be excluded irreversibly from the study procedure assessment process
- Participants unable to undergo tracheal aspiration as required for pain assessment procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are recruited from ICUs of participating hospitals between June and December 2025.
Duration - Up to 28 days or until hospital discharge
Participants undergo observational assessments related to pain and ventilatory parameters while mechanically ventilated in the ICU.
2 assessment visits: one on the second day after mechanical ventilation begins and one on the first day after sedation is reduced or suspended, with ongoing data collection up to 28 days.
Trial Site Locations
Total: 4 locations
1
Hospital Central da Aeronáutica
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
2
Hospital Central da Polícia Militar do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
3
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
4
Hospital Universitário Gafrée Guinle
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
Research Team
A
Arthur S Ferreira, Dsc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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