About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patientes admitted in ICU's in use of invasive mechanical ventilation
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Ventilatory Settings
All participants will be evaluated in relation to the ventilatory parameters used in the pain assessment measurement.
Airway occlusion pressure(P0.1)
All participants will have their expiratory occlusion pressure measured in the first 100 milliseconds of inspiration(P0.1, cmH2O), using the mechanical ventilator's own algorithm. When the P0.1 measurement button is pressed, the inspiratory flow valve is closed to prevent gas from flowing into the lungs during the measurement. The pressure is recorded 100 ms after the start of the inspiratory effort. Three measurements will be taken with a 1-minute interval between each one. The average of the three measurements will be calculated according to previous studies.
Patient-mechanical ventilator asynchrony index
The asynchrony index (AI) was defined by previous studies by the number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (patient-triggered) and of wasted efforts: asynchrony index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles + ineffective triggering) × 100. As previously reported, a high incidence of asynchrony was defined as an asynchrony index greater than 10%.
28-day mortality
Proportion of participants who died within 28 days after randomization/study enrollment
Sponsors and contacts
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Centro Universitário Augusto Motta
Lead sponsor
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