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

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ClinicalTrials.gov Identifier: NCT03773874
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Susana Arias Rivera, Hospital Universitario Getafe

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.

Condition or disease Intervention/treatment
Pain Sedation Agitation Delirium Restraint, Physical Critical Care Nursing Assessment Other: Assessment

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1574 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : February 25, 2018
Actual Study Completion Date : March 11, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Assessment
    Evaluation
    Other Name: audit


Primary Outcome Measures :
  1. 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

  2. "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

  3. 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.

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. protocols of pain and sedation [ Time Frame: one day ]
    Presence of protocols in the critical care units

  12. protocols of use of physical restraints [ Time Frame: one day ]
    Presence of protocols in the critical care units

  13. protocols of management of delirium [ Time Frame: one day ]
    Presence of protocols in the critical care units



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773874


Locations
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Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
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Principal Investigator: Susana Arias-Rivera, RN Hospital Universitario de Getafe
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susana Arias Rivera, Principal Investigator, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT03773874    
Other Study ID Numbers: PY 17/22
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders