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

Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035436
• Other study ID #: S-20130025c
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Critical Illness
• Delirium

Intervention

Other:
• Non-sedation
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
• 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.

Locations

Country	Name	City	State
Denmark	Lillebaelt Hospital, Kolding, Intensive Care Unit	Kolding

Sponsors (4)

Lead Sponsor	Collaborator
Palle Toft	Kolding Sygehus, The Danish Council for Strategic Research, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Attention/concentration	T-score in the two groups for the cognitive domaine attention/concentration	3 months after discharge from ICU
Secondary	Learning/memory	t-score in the two groups for the cognitive domaine: learning/memory	3 months after discharge from ICU
Secondary	Executive dysfunction	t-score in the two groups for the cognitive domaine: executive dysfunction	3 months after discharge from ICU
Secondary	Mental pace	t-score in the two groups for the cognitive domaine: mental pace	3 months after discharge from ICU
Secondary	Hypoactive delirium	Occurrence of hypoactive delirium (RASS = 0, CAM-ICU positive) in each group related to cognitive function at follow up	3 months after discharge from ICU
Secondary	Agitated delirium	Occurrence of agitated delirium (RASS = +2, CAM-ICU positive) in each group related to cognitive function at follow up	3 months after discharge from ICU