Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units
NCT ID: NCT03773874
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1574 participants
OBSERVATIONAL
2018-02-12
2018-03-11
Brief Summary
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Detailed Description
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At the same time, the level of pain, sedation / agitation and presence of delirium were evaluated in all adult patients who were admitted to the participating units with a minimum stay of 24 hours in the unit.
Process In order to obtain the largest representation of Spanish Intensive Care Units, a network of research nurses was created with coordinators in each autonomous community. The function of the coordinators was to contact and recruit units of adult critical patients within their community. Each coordinator contacted the centers (public and private), creating a network of collaborating nurses from those units who expressed their willingness to participate and who obtained the authorization of their Research Ethics Committee. Each unit was asked to contact a collaborating nurse for the project.
Once the national network of collaborating nurses was created, through the community coordinators, each password was given to each nurse to access the platform created for data entry. The platform offered access to all the documents (methodology, timeline, recommended assessment tools, navigation tutorial for the platform).
Data collection The tool used was an ad hoc survey with online access which consisted of 2 blocks. The first block asked about the characteristics of the units, the nurse-patient ratio, the existence of protocols and the usual practice for the control of pain, sedation / agitation, delirium and the use of mechanical restraints in the unit.
In the second block, questions were asked about aspects of direct assistance to patients, and direct evaluation of pain level, sedation / agitation of patients as well as the presence of delirium and mechanical containment.
Evaluation of patients included The data collection was done by direct observation and in the same period in all participating units. These data were entered into the platform through a "Patient Code", created automatically by the system.
To assess pain in patients, the investigators used two scales, for patients with the ability to communicate, the Visual Analogue Scale (VAS) scale was recommended and for patients without the ability to communicate the Scale of Behavioral Indicators of Pain (ESCID). The evaluation of the level of sedation / agitation was recommended to be carried out with the Richmond Agitation Sedation Scale (RASS) and delirium with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
The data on the use of tools to assess pain, sedation / agitation and delirium, as well as the recording of the use of mechanical restraints, were collected retrospectively on the nursing records of the patients evaluated, the day after their assessment.
Statistic analysis First, a descriptive analysis was made of the general characteristics of the participating units and the study population, presenting the data with means and standard deviations (SD) or medians and interquartile ranges (RIC), as appropriate. Group comparison was performed with the Student t test for quantitative variables or nonparametric tests, as appropriate, and Fischer's test or chi-square for qualitative variables. The data was analyzed with the statistical package IBM SPSS Statistics 21.0 for Windows
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Assessment
Evaluation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital Universitario Getafe
OTHER
Responsible Party
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Susana Arias Rivera
Principal Investigator
Principal Investigators
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Susana Arias-Rivera, RN
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Getafe
Locations
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Hospital Universitario de Getafe
Getafe, Madrid, Spain
Countries
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References
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Arias-Rivera S, Lopez-Lopez C, Frade-Mera MJ, Via-Clavero G, Rodriguez-Mondejar JJ, Sanchez-Sanchez MM, Acevedo-Nuevo M, Gil-Castillejos D, Robleda G, Cachon-Perez M, Latorre-Marco I; Equipo ASCyD. Assessment of analgesia, sedation, physical restraint and delirium in patients admitted to Spanish intensive care units. Proyecto ASCyD. Enferm Intensiva (Engl Ed). 2020 Jan-Mar;31(1):3-18. doi: 10.1016/j.enfi.2018.11.002. Epub 2019 Apr 16. English, Spanish.
Other Identifiers
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PY 17/22
Identifier Type: -
Identifier Source: org_study_id