A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.
Non-commercial study. The study complies with the ethical principles of the Declaration of Helsinki, the recommendations of Good Clinical Practice (GCP) and current legislation. The study has been approved with a favorable opinion by the CEIm of the Hospital Universitario 12 de Octubre. Written consent will be requested from the participants and / or their relatives / representatives to participate in the study.
Study Type
OBSERVATIONAL
Enrollment
300
The pain of the subjects will be evaluated by two independent observers and with a blind result between them, coinciding with the application of two painful procedures used in routine practice: suction of tracheal secretions and the pressure in the nail bed by means of a pressure algometer. In addition, a painless procedure will also be performed to establish an element of control with the procedures painful. This will consist of the application of gentle friction with a cloth gauze, on a part of healthy skin tissue of the patient. The measurement will be performed twice for each patient and procedure depending on the level of sedation, so that the first measurement will be performed with a deeper sedation level and the second with a change in sedation level to moderate-mild. In turn, the pain assessment will be carried out in three moments: first or baseline measurement, during the application of the painless and 15 minutes after finishing the procedures.
Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
RECRUITINGTo assess the construct validity and the reliability
Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage
Time frame: 30 months
To assess pain from different procedures with ESCID-DC scale
Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Indicator Behavior Scale of Pain in a Patient with Brain Damage (ESCID-DC)
Time frame: 30 months
To assess pain from different procedures with NCS-R scale
Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Nociception Coma Scale-Revised (NCS-R)
Time frame: 30 months
To analyze the scale under different etiology of brain damage
Pain score of patients with different etiology of brain damage (ischemic, traumatic and / or post-anoxic encephalopathy)
Time frame: 30 months
To analyze the scale under different levels of consciousness
Pain score of patients with different levels of consciousness (severe: Glasgow Coma Score \<9 / moderate: Glasgow Coma Score 9-13 / mild: Glasgow Coma Score 14-15)
Time frame: 30 months
To analyze the scale under different degrees of sedation
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Pain score of patients with different degrees of sedation (deep sedation: Richmond Agitation-Sedation Scale (RASS) Score -5, -4 / moderate sedation: Richmond Agitation-Sedation Scale (RASS) Score -3 and/or light sedation Richmond Agitation-Sedation Scale (RASS) Score -2, -1)
Time frame: 30 months