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

NCT02035436 | Completed DMC

• 1 other identifier: S-20130025c
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Cognition Disorders

Keywords

Respiration, artificial; Critcal care

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  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)

  3 months after discharge from ICU

Secondary Outcomes (6)

• Attention/concentration

  3 months after discharge from ICU

• Learning/memory

  3 months after discharge from ICU

• Executive dysfunction

  3 months after discharge from ICU

• Mental pace

  3 months after discharge from ICU

• Hypoactive delirium

  3 months after discharge from ICU

Study Arms (2)

Non-sedation

EXPERIMENTAL

Non-sedation supplemented with pain management during mechanical ventilation.

Other: Non-sedation

Sedation

ACTIVE COMPARATOR

Current gold standard: Sedation with a daily wake-up trial.

Other: Control: Sedation

Interventions

Non-sedation OTHER

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

Non-sedation

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.

Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palle Toft: lead
• Kolding Sygehus: collaborator
• University of Southern Denmark: collaborator
• The Danish Council for Strategic Research: collaborator

Study Sites (1)

Lillebaelt Hospital, Kolding, Intensive Care Unit

Kolding, 6000, Denmark

Location

Related Publications (1)

• Nedergaard HK, Jensen HI, Stylsvig M, Lauridsen JT, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial. Trials. 2016 Jun 1;17(1):269. doi: 10.1186/s13063-016-1390-5.

  PMID: 27250658 DERIVED

MeSH Terms

Conditions

Delirium; Cognition Disorders; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Helene Joergensen, MD

  Lillebaelt Hospital, Kolding

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

DK (1)