Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units (ASCyD)

December 11, 2018 updated by: Susana Arias Rivera, Hospital Universitario Getafe

Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project

This study assess which Spanish intensive care units evaluate and record, in a standardized way, levels of pain, sedation / agitation, use of physical restraints and prevalence of delirium. Also determine the use of validated assessment tools and explore levels of pain and sedation / agitation, use of physical restraints and prevalence of delirium.

Study Overview

Detailed Description

An observational, descriptive, cross-sectional, prospective and multicenter study was conducted to know the usual practice (audit) in critical care units and about the assessment of pain, sedation, delirium and the use of mechanical restraints.

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

Study Type

Observational

Enrollment (Actual)

1574

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients who were admitted to the participating units at the time of the audit and had a minimum stay of 24 hours in the unit.

Description

Inclusion Criteria:

  • All adult patients who were admitted to the participating units at the time of the audit and had a minimum stay of 24 hours in the unit.

Exclusion Criteria:

  • no criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.
Time Frame: one day
Primary assessment of pain. NRS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain
one day
"Non communicative" patient's pain with Behavioural Indicators of Pain Scale (ESCID) in critical care units.
Time Frame: one day
Primary assessment of pain ESCID scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain
one day
Communicative and "no communicative" patient's sedation/agitation level's with Richmond Agitation Sedation Scale (RASS) in critcal care units.
Time Frame: one day
Primary assessment of sedation/agitation level' s. RASS scale range from -5 to +5. -4 to -5: depth sedation; -3 to -1: light sedation; 0: aware; +1 to +4: agitation.
one day
Communicative and "no communicative" patient's delirium prevalence with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in critical care units
Time Frame: one day
Primary assessment of delirium
one day
Use of physical restraints on Communicative and "no communicative" patient's in critical care units
Time Frame: one day
Primary assessment of use of physical restraints
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
use of validated scale of pain: Numeric Rating Scale (NRS)
Time Frame: one day
use of validated scales of pain for communicative patients. NRS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.
one day
use of validated scale of pain: Visual Analog Scale (VAS)
Time Frame: one day
use of validated scales of pain for communicative patients. VAS, scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.
one day
use of validated scale of pain: Campbell scale
Time Frame: one day
use of validated scales of pain for "non communicative" patients. Campbell scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.
one day
use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)
Time Frame: one day
use of validated scales of pain for "non communicative" patients. ESCID scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.
one day
use of validated scales of pain: Behavioral Pain Scale (BPS)
Time Frame: one day
use of validated scales of pain for "non communicative" patients. scale's range from 3 to 12; 3: no pain, high number more pain.
one day
use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)
Time Frame: one day
use of validated scales of pain for "non communicative" patients. CPOT: range from 0 to 8; 0-2: no pain, > 2 pain.
one day
use of validated scales of sedation/agitation (RASS)
Time Frame: one day
use of validated scales of sedation/agitation patients. RASS scale range from -5 to +5. -4 to -5: depth sedation; -3 to -1: light sedation; 0: aware; +1 to +4: agitation.
one day
use of validated scales of sedation/agitation (Ramsay scale)
Time Frame: one day
use of validated scales of sedation/agitation patients. Ramsay score from 1 to 6; 1: anxious, agitated restless, 2: cooperative, oriented, tranquil, 3: responsive to commands only, 4: brisk response to light glabellar tap or loud auditory stimulus, 5: sluggish response to light glabellar tap or loud auditory stimulus, 6: no response to light glabellar tap or loud auditory stimulus.
one day
use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))
Time Frame: one day
Use of validated scales of delirium. ICDSC is positive (delirium present) or negative (no delirium).
one day
use of validated scales of delirium (CAM-ICU)
Time Frame: one day
Use of validated scales of delirium. CAM-ICU is positive (delirium present) or negative (no delirium).
one day
protocols of pain and sedation
Time Frame: one day
Presence of protocols in the critical care units
one day
protocols of use of physical restraints
Time Frame: one day
Presence of protocols in the critical care units
one day
protocols of management of delirium
Time Frame: one day
Presence of protocols in the critical care units
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susana Arias-Rivera, RN, Hospital Universitario de Getafe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2018

Primary Completion (Actual)

February 25, 2018

Study Completion (Actual)

March 11, 2018

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Assessment

3
Subscribe