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Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function

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ClinicalTrials.gov Identifier: NCT02035436
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Kolding Sygehus
University of Southern Denmark
The Danish Council for Strategic Research
Information provided by (Responsible Party):
Palle Toft, Odense University Hospital

Brief Summary:

Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on delirium during admission and cognitive function after discharge from ICU.

Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.


Condition or disease Intervention/treatment Phase
Delirium Cognition Disorders Other: Non-sedation Other: Control: Sedation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Substudy of the NONSEDA Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Non-sedation
Non-sedation supplemented with pain management during mechanical ventilation.
Other: Non-sedation
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.

Active Comparator: Sedation
Current gold standard: Sedation with a daily wake-up trial.
Other: Control: Sedation
Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.




Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 3 months after discharge from ICU ]

    Cognitive t-score, in percentage, difference between the two groups. The t-score for each patient will be diagnosed by the neuropsycologist at a personal interview and use of following tests:

    • Span of numbers
    • Coding test
    • Trailmaking A+B
    • Rey auditory verbal learning test (immediate, recall)
    • Rey-Ostherrieth complex figure test (immediate, recall, recognition)
    • Word finding test (S-word, animals)
    • Stroop test (congruent+incongruent)


Secondary Outcome Measures :
  1. Attention/concentration [ Time Frame: 3 months after discharge from ICU ]
    T-score in the two groups for the cognitive domaine attention/concentration

  2. Learning/memory [ Time Frame: 3 months after discharge from ICU ]
    t-score in the two groups for the cognitive domaine: learning/memory

  3. Executive dysfunction [ Time Frame: 3 months after discharge from ICU ]
    t-score in the two groups for the cognitive domaine: executive dysfunction

  4. Mental pace [ Time Frame: 3 months after discharge from ICU ]
    t-score in the two groups for the cognitive domaine: mental pace

  5. Hypoactive delirium [ Time Frame: 3 months after discharge from ICU ]
    Occurrence of hypoactive delirium (RASS ≤ 0, CAM-ICU positive) in each group related to cognitive function at follow up

  6. Agitated delirium [ Time Frame: 3 months after discharge from ICU ]
    Occurrence of agitated delirium (RASS ≥ +2, CAM-ICU positive) in each group related to cognitive function at follow up



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

Inclusion Criteria:

  • Endotracheally intubated
  • Expected time on ventilator > 24 hours
  • Age ≥ 18 years
  • Informed consent

Exclusion Criteria:

  • Severe head trauma where therapeutic coma is indicated
  • Therapeutic hypothermia where therapeutic coma is indicated
  • Status epilepticus where therapeutic coma is indicated
  • Patient has participated in the study before
  • Patient is transferred from another ICU with length of stay > 48 hours
  • Patient is comatose at admission
  • PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
  • Patient does not speak Danish, swedish or norwegian at a reasonable level

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): NCT02035436


Locations
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Denmark
Lillebaelt Hospital, Kolding, Intensive Care Unit
Kolding, Denmark, 6000
Sponsors and Collaborators
Palle Toft
Kolding Sygehus
University of Southern Denmark
The Danish Council for Strategic Research
Investigators
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Principal Investigator: Helene Joergensen, MD Lillebaelt Hospital, Kolding
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Palle Toft, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02035436    
Other Study ID Numbers: S-20130025c
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by Palle Toft, Odense University Hospital:
Respiration, artificial
Critcal care
Additional relevant MeSH terms:
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Delirium
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders