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NCT Number: NCT02035436

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

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.

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Key information

Conditions

Delirium Cognition Disorders Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lillebaelt Hospital, Kolding, Intensive Care Unit

Kolding, 6000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-sedation

Other

Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.

Control: Sedation

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Palle Toft

Other

Collaborators

  • Kolding Sygehus
  • The Danish Council for Strategic Research
  • University of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jan 14, 2014
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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