Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function
NCT02035436, Not applicable, Completed, Palle Toft
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function | ClinicalTrials.gov |
| NCT number | NCT02035436 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 205 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Palle Toft | ClinicalTrials.gov |
| Conditions | Delirium, Cognition Disorders | ClinicalTrials.gov |
| Interventions | Non-sedation, Control: Sedation | ClinicalTrials.gov |
| First posted | 2014-01-14 | ClinicalTrials.gov |
| Last updated | 2019-03-15 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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) | ClinicalTrials.gov |
| Secondary | Attention/concentration | 3 months after discharge from ICU | T-score in the two groups for the cognitive domaine attention/concentration | ClinicalTrials.gov |
| Secondary | Learning/memory | 3 months after discharge from ICU | t-score in the two groups for the cognitive domaine: learning/memory | ClinicalTrials.gov |
| Secondary | Executive dysfunction | 3 months after discharge from ICU | t-score in the two groups for the cognitive domaine: executive dysfunction | ClinicalTrials.gov |
| Secondary | Mental pace | 3 months after discharge from ICU | t-score in the two groups for the cognitive domaine: mental pace | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 27250658 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)