Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 4
- 主要终点
- Pain Intensity by BPS
研究概览
简要总结
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.
详细描述
PARTICIPANTS AND METHODS
ETHICAL ASPECTS
This project was submitted to the Ethics and Research Committee (CEP) of UNISUAM, via Platform Brazil, by the project coordinating center and will have the consent of all participating institutions, as per and predicted in the standards from the Resolution 466/12, of Advice National of Health (CNS) (Brazil, 2012) and in Law 14,874/2024, which establishes the National System of Ethics in Research with Human Beings (Brazil, 2024) and approved under number: 83431424.8.1001.5235 . Like this, the investigators ensure what principles ethical will be followed to the far away from the search, with one commitment explicit of respect the autonomy and these values of participants, while ensuring the confidentiality of data. All data will be reported later following the recommendations of STROBE ( STRengthening the Reporting of Observational studies in Epidemiology).
LOCATION OF REALIZATION OF STUDY
The study will be a multicenter study involving public and private hospitals, with the coordinating center of the study being the Augusto Motta University Center
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Pain Intensity by BPS
时间窗: From second day after enrollment , from first day at RASS -2 or minus, with end point 28 - day.
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
时间窗: Time Frame: From second day after enrollment , from first day at RASS -2 or minus, with end point 28 - day.
The intensity of pain will be assessment by Critical care pain observation tool (CPOT) in the morning after the first tracheal suctioning procedure.
次要结局
- Ventilatory Settings(From second day after enrollment, from first day at RASS-2 or minus, with end point 28-day")
- Time to weaning from mechanical ventilation(Up to 28 days)
- 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)