- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773874
Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units (ASCyD)
Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Madrid
-
Getafe, Madrid, Spain, 28905
- Hospital Universitario de Getafe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Susana Arias-Rivera, RN, Hospital Universitario de Getafe
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PY 17/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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