NCT03773874

Brief 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. Also determine the use of validated assessment tools and explore levels of pain and sedation / agitation, use of physical restraints and prevalence of delirium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,574

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
Last Updated

December 12, 2018

Status Verified

February 1, 2018

Enrollment Period

13 days

First QC Date

October 9, 2018

Last Update Submit

December 11, 2018

Conditions

PainSedationAgitationDeliriumRestraint, PhysicalCritical CareNursing Assessment

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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.

    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

    one day

  • Use of physical restraints on Communicative and "no communicative" patient's in critical care units

    Primary assessment of use of physical restraints

    one day

Secondary Outcomes (13)

  • use of validated scale of pain: Numeric Rating Scale (NRS)

    one day

  • use of validated scale of pain: Visual Analog Scale (VAS)

    one day

  • use of validated scale of pain: Campbell scale

    one day

  • use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)

    one day

  • use of validated scales of pain: Behavioral Pain Scale (BPS)

    one day

  • +8 more secondary outcomes

Interventions

AssessmentOTHER

Evaluation

Also known as: audit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • no criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31003871DERIVED

MeSH Terms

Conditions

PainPsychomotor AgitationDelirium

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorConfusionNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Susana Arias-Rivera, RN

    Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

December 12, 2018

Study Start

February 12, 2018

Primary Completion

February 25, 2018

Study Completion

March 11, 2018

Last Updated

December 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)