PainASCyDNCT03773874
Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units
An observational study of Pain and Sedation, run by Hospital Universitario Getafe at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Assessment
- How many people
- 1,574 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2018to 11 Mar 2018
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- no criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Pain, Sedation, Agitation, Delirium, Restraint, Physical, Critical Care
- Being tested
- Assessment
- Medical subject headings
- Pain, Psychomotor Agitation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Also called audit
Evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.
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
Measured: one day
"Non communicative" patient's pain with Behavioural Indicators of Pain Scale (ESCID) in critical care units.
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
Measured: one day
Communicative and "no communicative" patient's sedation/agitation level's with Richmond Agitation Sedation Scale (RASS) in critcal care units.
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.
Measured: 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
Primary assessment of delirium
Measured: one day
Use of physical restraints on Communicative and "no communicative" patient's in critical care units
Primary assessment of use of physical restraints
Measured: one day
Secondary outcomes (13)
use of validated scale of pain: Numeric Rating Scale (NRS)
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.
Measured: one day
use of validated scale of pain: Visual Analog Scale (VAS)
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.
Measured: one day
use of validated scale of pain: Campbell scale
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.
Measured: one day
use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)
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.
Measured: one day
use of validated scales of pain: Behavioral Pain Scale (BPS)
use of validated scales of pain for "non communicative" patients. scale's range from 3 to 12; 3: no pain, high number more pain.
Measured: one day
use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)
use of validated scales of pain for "non communicative" patients. CPOT: range from 0 to 8; 0-2: no pain, > 2 pain.
Measured: one day
use of validated scales of sedation/agitation (RASS)
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.
Measured: one day
use of validated scales of sedation/agitation (Ramsay scale)
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.
Measured: one day
use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))
Use of validated scales of delirium. ICDSC is positive (delirium present) or negative (no delirium).
Measured: one day
use of validated scales of delirium (CAM-ICU)
Use of validated scales of delirium. CAM-ICU is positive (delirium present) or negative (no delirium).
Measured: one day
protocols of pain and sedation
Presence of protocols in the critical care units
Measured: one day
protocols of use of physical restraints
Presence of protocols in the critical care units
Measured: one day
protocols of management of delirium
Presence of protocols in the critical care units
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start12 Feb 2018
- Primary completion25 Feb 2018
- Study completion11 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,574 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Arias Rivera, Hospital Universitario Getafe
- Investigators
- Susana Arias-Rivera, RN, Principal investigator, Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773874
- Sponsor's protocol ID
- PY 17/22
- Acronym
- ASCyD
- Status last verified
- Feb 2018
- First submitted
- 9 Oct 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31003871
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project
- ClinicalTrials.gov ID
- NCT03773874
- Acronym / sponsor ID
- ASCyD / PY 17/22
- Conditions
- Pain, Sedation, Agitation, Delirium, Restraint, Physical, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,574 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 11 Mar 2018 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- no criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentAlso: auditEvaluation | Other | – |
Primary outcome
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
"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
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.
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
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
13 secondary outcomes
use of validated scale of pain: Numeric Rating Scale (NRS)
Time frame: one day
use of validated scale of pain: Visual Analog Scale (VAS)
Time frame: one day
use of validated scale of pain: Campbell scale
Time frame: one day
use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)
Time frame: one day
use of validated scales of pain: Behavioral Pain Scale (BPS)
Time frame: one day
use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)
Time frame: one day
use of validated scales of sedation/agitation (RASS)
Time frame: one day
use of validated scales of sedation/agitation (Ramsay scale)
Time frame: one day
use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))
Time frame: one day
use of validated scales of delirium (CAM-ICU)
Time frame: one day
protocols of pain and sedation
Time frame: one day
protocols of use of physical restraints
Time frame: one day
protocols of management of delirium
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Derived from this study: PubMed 31003871Arias-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Arias-Rivera, RN principal investigator
Hospital Universitario de Getafe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Sedation, run by Hospital Universitario Getafe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units. (time frame: one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.