<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773874</url>
  </required_header>
  <id_info>
    <org_study_id>PY 17/22</org_study_id>
    <nct_id>NCT03773874</nct_id>
  </id_info>
  <brief_title>Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units</brief_title>
  <acronym>ASCyD</acronym>
  <official_title>Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Getafe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Getafe</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assess which Spanish intensive care units evaluate and record, in a standardized&#xD;
      way, levels of pain, sedation / agitation, use of physical restraints and prevalence of&#xD;
      delirium. Also determine the use of validated assessment tools and explore levels of pain and&#xD;
      sedation / agitation, use of physical restraints and prevalence of delirium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An observational, descriptive, cross-sectional, prospective and multicenter study was&#xD;
      conducted to know the usual practice (audit) in critical care units and about the assessment&#xD;
      of pain, sedation, delirium and the use of mechanical restraints.&#xD;
&#xD;
      At the same time, the level of pain, sedation / agitation and presence of delirium were&#xD;
      evaluated in all adult patients who were admitted to the participating units with a minimum&#xD;
      stay of 24 hours in the unit.&#xD;
&#xD;
      Process In order to obtain the largest representation of Spanish Intensive Care Units, a&#xD;
      network of research nurses was created with coordinators in each autonomous community. The&#xD;
      function of the coordinators was to contact and recruit units of adult critical patients&#xD;
      within their community. Each coordinator contacted the centers (public and private), creating&#xD;
      a network of collaborating nurses from those units who expressed their willingness to&#xD;
      participate and who obtained the authorization of their Research Ethics Committee. Each unit&#xD;
      was asked to contact a collaborating nurse for the project.&#xD;
&#xD;
      Once the national network of collaborating nurses was created, through the community&#xD;
      coordinators, each password was given to each nurse to access the platform created for data&#xD;
      entry. The platform offered access to all the documents (methodology, timeline, recommended&#xD;
      assessment tools, navigation tutorial for the platform).&#xD;
&#xD;
      Data collection The tool used was an ad hoc survey with online access which consisted of 2&#xD;
      blocks. The first block asked about the characteristics of the units, the nurse-patient&#xD;
      ratio, the existence of protocols and the usual practice for the control of pain, sedation /&#xD;
      agitation, delirium and the use of mechanical restraints in the unit.&#xD;
&#xD;
      In the second block, questions were asked about aspects of direct assistance to patients, and&#xD;
      direct evaluation of pain level, sedation / agitation of patients as well as the presence of&#xD;
      delirium and mechanical containment.&#xD;
&#xD;
      Evaluation of patients included The data collection was done by direct observation and in the&#xD;
      same period in all participating units. These data were entered into the platform through a&#xD;
      &quot;Patient Code&quot;, created automatically by the system.&#xD;
&#xD;
      To assess pain in patients, the investigators used two scales, for patients with the ability&#xD;
      to communicate, the Visual Analogue Scale (VAS) scale was recommended and for patients&#xD;
      without the ability to communicate the Scale of Behavioral Indicators of Pain (ESCID). The&#xD;
      evaluation of the level of sedation / agitation was recommended to be carried out with the&#xD;
      Richmond Agitation Sedation Scale (RASS) and delirium with the Confusion Assessment Method&#xD;
      for the Intensive Care Unit (CAM-ICU).&#xD;
&#xD;
      The data on the use of tools to assess pain, sedation / agitation and delirium, as well as&#xD;
      the recording of the use of mechanical restraints, were collected retrospectively on the&#xD;
      nursing records of the patients evaluated, the day after their assessment.&#xD;
&#xD;
      Statistic analysis First, a descriptive analysis was made of the general characteristics of&#xD;
      the participating units and the study population, presenting the data with means and standard&#xD;
      deviations (SD) or medians and interquartile ranges (RIC), as appropriate. Group comparison&#xD;
      was performed with the Student t test for quantitative variables or nonparametric tests, as&#xD;
      appropriate, and Fischer's test or chi-square for qualitative variables. The data was&#xD;
      analyzed with the statistical package IBM SPSS Statistics 21.0 for Windows&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Actual">March 11, 2018</completion_date>
  <primary_completion_date type="Actual">February 25, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.</measure>
    <time_frame>one day</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;Non communicative&quot; patient's pain with Behavioural Indicators of Pain Scale (ESCID) in critical care units.</measure>
    <time_frame>one day</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Communicative and &quot;no communicative&quot; patient's sedation/agitation level's with Richmond Agitation Sedation Scale (RASS) in critcal care units.</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Communicative and &quot;no communicative&quot; patient's delirium prevalence with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in critical care units</measure>
    <time_frame>one day</time_frame>
    <description>Primary assessment of delirium</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of physical restraints on Communicative and &quot;no communicative&quot; patient's in critical care units</measure>
    <time_frame>one day</time_frame>
    <description>Primary assessment of use of physical restraints</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>use of validated scale of pain: Numeric Rating Scale (NRS)</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scale of pain: Visual Analog Scale (VAS)</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scale of pain: Campbell scale</measure>
    <time_frame>one day</time_frame>
    <description>use of validated scales of pain for &quot;non communicative&quot; patients. Campbell scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)</measure>
    <time_frame>one day</time_frame>
    <description>use of validated scales of pain for &quot;non communicative&quot; patients. ESCID scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scales of pain: Behavioral Pain Scale (BPS)</measure>
    <time_frame>one day</time_frame>
    <description>use of validated scales of pain for &quot;non communicative&quot; patients. scale's range from 3 to 12; 3: no pain, high number more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)</measure>
    <time_frame>one day</time_frame>
    <description>use of validated scales of pain for &quot;non communicative&quot; patients. CPOT: range from 0 to 8; 0-2: no pain, &gt; 2 pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scales of sedation/agitation (RASS)</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scales of sedation/agitation (Ramsay scale)</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))</measure>
    <time_frame>one day</time_frame>
    <description>Use of validated scales of delirium. ICDSC is positive (delirium present) or negative (no delirium).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of validated scales of delirium (CAM-ICU)</measure>
    <time_frame>one day</time_frame>
    <description>Use of validated scales of delirium. CAM-ICU is positive (delirium present) or negative (no delirium).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>protocols of pain and sedation</measure>
    <time_frame>one day</time_frame>
    <description>Presence of protocols in the critical care units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>protocols of use of physical restraints</measure>
    <time_frame>one day</time_frame>
    <description>Presence of protocols in the critical care units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>protocols of management of delirium</measure>
    <time_frame>one day</time_frame>
    <description>Presence of protocols in the critical care units</description>
  </secondary_outcome>
  <enrollment type="Actual">1574</enrollment>
  <condition>Pain</condition>
  <condition>Sedation</condition>
  <condition>Agitation</condition>
  <condition>Delirium</condition>
  <condition>Restraint, Physical</condition>
  <condition>Critical Care</condition>
  <condition>Nursing Assessment</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment</intervention_name>
    <description>Evaluation</description>
    <other_name>audit</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients who were admitted to the participating units at the time of the audit&#xD;
        and had a minimum stay of 24 hours in the unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients who were admitted to the participating units at the time of the&#xD;
             audit and had a minimum stay of 24 hours in the unit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susana Arias-Rivera, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario de Getafe</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario de Getafe</name>
      <address>
        <city>Getafe</city>
        <state>Madrid</state>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Getafe</investigator_affiliation>
    <investigator_full_name>Susana Arias Rivera</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773874
org study id: PY 17/22
nct id: NCT03773874
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.
time frame: one day
description: 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
measure: "Non communicative" patient's pain with Behavioural Indicators of Pain Scale (ESCID) in critical care units.
time frame: one day
description: 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
measure: Communicative and "no communicative" patient's sedation/agitation level's with Richmond Agitation Sedation Scale (RASS) in critcal care units.
time frame: one day
description: 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.
measure: 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
description: Primary assessment of delirium
measure: Use of physical restraints on Communicative and "no communicative" patient's in critical care units
time frame: one day
description: Primary assessment of use of physical restraints
measure: use of validated scale of pain: Numeric Rating Scale (NRS)
time frame: one day
description: 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.
measure: use of validated scale of pain: Visual Analog Scale (VAS)
time frame: one day
description: 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.
measure: use of validated scale of pain: Campbell scale
time frame: one day
description: 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.
measure: use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)
time frame: one day
description: 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.
measure: use of validated scales of pain: Behavioral Pain Scale (BPS)
time frame: one day
description: use of validated scales of pain for "non communicative" patients. scale's range from 3 to 12; 3: no pain, high number more pain.
measure: use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)
time frame: one day
description: use of validated scales of pain for "non communicative" patients. CPOT: range from 0 to 8; 0-2: no pain, > 2 pain.
measure: use of validated scales of sedation/agitation (RASS)
time frame: one day
description: 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.
measure: use of validated scales of sedation/agitation (Ramsay scale)
time frame: one day
description: 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.
measure: use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))
time frame: one day
description: Use of validated scales of delirium. ICDSC is positive (delirium present) or negative (no delirium).
measure: use of validated scales of delirium (CAM-ICU)
time frame: one day
description: Use of validated scales of delirium. CAM-ICU is positive (delirium present) or negative (no delirium).
measure: protocols of pain and sedation
time frame: one day
description: Presence of protocols in the critical care units
measure: protocols of use of physical restraints
time frame: one day
description: Presence of protocols in the critical care units
measure: protocols of management of delirium
time frame: one day
description: Presence of protocols in the critical care units
intervention type: Other
intervention name: Assessment
description: Evaluation
other name: audit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susana Arias-Rivera, RN
role: Principal Investigator
affiliation: Hospital Universitario de Getafe
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Getafe
investigator full name: Susana Arias Rivera
investigator title: Principal Investigator
mesh term: Delirium
sharing ipd: No