Non-sedation-Does it improve health-related quality of life after critical illness? A 3-month follow-up sub-study of the NONSEDA trial.

BACKGROUND: Critical illness is associated with severely impaired health-related quality of life (HRQoL) for years following discharge. The NONSEDA trial was a multicenter randomized trial on non-sedation versus sedation with a daily wake-up trial in critically ill, mechanically ventilated patients in Scandinavia. The aim of this sub-study was to assess the effect of non-sedation on HRQoL and degree of independence in activities in daily living (ADL) 3 months post-ICU. METHODS: All survivors were asked to complete the Medical Outcomes Study Short-Form 36 questionnaire (SF-36) and the Barthel Index 3 months post-ICU. To limit missing data, reminders were sent. If unsuccessful, telephone interviews could be used. Outcomes were the level of HRQoL and ADL-function in each group. All outcomes were assessed blinded. RESULTS: Of the 700 patients included 412 survived to follow-up. A total of 344 survivors participated (82%). Baseline data were equal between the two groups. Mean SF-36 scores for the non-sedated vs sedated patients were as follows: Physical Function 45 vs 40, P = .69, Bodily Pain: 61 vs 52, P = .81, General Health: 50 vs 50, P = .84, Vitality: 42 vs 44, P = .85, Social Function: 75 vs 63, P = .85, Role Emotional: 58 vs 50, P = .82, Mental Health: 70 vs 70, P = .89, Role Physical: 25 vs 28, P = .32, Physical Component Score: 38 vs 37, P = .81, Mental Component Score: 48 vs 46, P = .94, Barthel Index: 20 vs 20, P = .74. CONCLUSION: Randomization to non-sedation neither improved nor impaired health-related quality of life or degree of independence in activities in daily living 3 months post-ICU discharge.

Effect of non-sedation on post-traumatic stress and psychological health in survivors of critical illness-A substudy of the NONSEDA randomized trial.

BACKGROUND: Critical illness can cause post-traumatic stress and impaired mental health. The NONSEDA trial was a Scandinavian multicenter RCT, assessing non-sedation versus sedation with a daily wake-up call during mechanical ventilation in critically ill adults. The aim of this substudy was to assess the effect of non-sedation on post-traumatic stress and mental health. METHODS: This substudy is based on all participating patients from a single NONSEDA trial site (Kolding, Denmark). Patients were randomized to sedation or non-sedation within the first 24 hours of mechanical ventilation. Three months after ICU discharge survivors were examined by a neuropsychologist for post-traumatic stress, anxiety and depression, and filled out the SF-36 questionnaire regarding quality of life. RESULTS: The two groups of survivors were similar with regard to baseline characteristics, length of admission and mechanical ventilation. Sedated patients received more propofol and midazolam. Doses of morphine and haloperidole were equal. PRIMARY OUTCOME: the number of patients with post-traumatic stress disorder did not differ between groups (non-sedated: 2 patients vs sedated: 0, P = .23). SECONDARY OUTCOMES: there were no differences between groups in Beck Anxiety Index (median, non-sedated: 0 vs sedated: 0, P = .62), Beck Depression Index (median, non-sedated: 7 vs sedated: 4, P = .24), SF-36 mental component score (mean, non-sedated: 46.7 vs sedated: 47.5, P = .73) or number of patients with symptoms of post-traumatic stress (8 in both groups, P = .89). CONCLUSION: Levels of PTSD, anxiety and depression and quality of life regarding mental health were similar between the non-sedated and sedated group.

Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients.

BACKGROUND: In critically ill, mechanically ventilated patients, daily interruption of sedation has been shown to reduce the time on ventilation and the length of stay in the intensive care unit (ICU). Data on whether a plan of no sedation, as compared with a plan of light sedation, has an effect on mortality are lacking. METHODS: In a multicenter, randomized, controlled trial, we assigned, in a 1:1 ratio, mechanically ventilated ICU patients to a plan of no sedation (nonsedation group) or to a plan of light sedation (i.e., to a level at which the patient was arousable, defined as a score of -2 to -3 on the Richmond Agitation and Sedation Scale [RASS], on which scores range from -5 [unresponsive] to +4 [combative]) (sedation group) with daily interruption. The primary outcome was mortality at 90 days. Secondary outcomes were the number of major thromboembolic events, the number of days free from coma or delirium, acute kidney injury according to severity, the number of ICU-free days, and the number of ventilator-free days. Between-group differences were calculated as the value in the nonsedation group minus the value in the sedation group. RESULTS: A total of 710 patients underwent randomization, and 700 were included in the modified intention-to-treat analysis. The characteristics of the patients at baseline were similar in the two trial groups, except for the score on the Acute Physiology and Chronic Health Evaluation (APACHE) II, which was 1 point higher in the nonsedation group than in the sedation group, indicating a greater chance of in-hospital death. The mean RASS score in the nonsedation group increased from -1.3 on day 1 to -0.8 on day 7 and, in the sedation group, from -2.3 on day 1 to -1.8 on day 7. Mortality at 90 days was 42.4% in the nonsedation group and 37.0% in the sedated group (difference, 5.4 percentage points; 95% confidence interval [CI], -2.2 to 12.2; P = 0.65). The number of ICU-free days and of ventilator-free days did not differ significantly between the trial groups. The patients in the nonsedation group had a median of 27 days free from coma or delirium, and those in the sedation group had a median of 26 days free from coma or delirium. A major thromboembolic event occurred in 1 patient (0.3%) in the nonsedation group and in 10 patients (2.8%) in the sedation group (difference, -2.5 percentage points; 95% CI, -4.8 to -0.7 [unadjusted for multiple comparisons]). CONCLUSIONS: Among mechanically ventilated ICU patients, mortality at 90 days did not differ significantly between those assigned to a plan of no sedation and those assigned to a plan of light sedation with daily interruption. (Funded by the Danish Medical Research Council and others; NONSEDA ClinicalTrials.gov number, NCT01967680.).