Prevalence of Pain in Mechanically Ventilated Patients in Intensive Care Units

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Universitário Augusto Motta

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

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

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

Secondary outcomes

1

Ventilatory Settings

All participants will be evaluated in relation to the ventilatory parameters used in the pain assessment measurement.

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

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.

Time frame
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.
3

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%.

Time frame
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.
4

28-day mortality

Proportion of participants who died within 28 days after randomization/study enrollment

Time frame
28 days

Other outcomes

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