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

Not Applicable

Completed

• Conditions: Cognition Disorders; Delirium
• Interventions: Other: Non-sedation

• Registration Number: NCT02035436
• Lead Sponsor: Palle Toft

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2017-06
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-sedation	Non-sedation	Non-sedation supplemented with pain management during mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Cognitive function	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

Name	Time	Method
Attention/concentration	3 months after discharge from ICU	T-score in the two groups for the cognitive domaine attention/concentration
Learning/memory	3 months after discharge from ICU	t-score in the two groups for the cognitive domaine: learning/memory
Executive dysfunction	3 months after discharge from ICU	t-score in the two groups for the cognitive domaine: executive dysfunction
Agitated delirium	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
Mental pace	3 months after discharge from ICU	t-score in the two groups for the cognitive domaine: mental pace
Hypoactive delirium	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

Trial Locations

Locations (1)

Lillebaelt Hospital, Kolding, Intensive Care Unit; 🇩🇰 Kolding, Denmark