A multicenter randomized controlled trial comparing three-times-a-day intermittent enteral postural feeding to continuous enteral feeding among mechanically ventilated patients in intensive care.

BACKGROUND AND AIMS: Previous randomized controlled trials (RCTs) comparing intermittent feeding versus continuous feeding used different methods, employed shorter fasting intervals, ignored patients' posture in bed during feeds, and showed mixed results. Prolonged fasting intervals are hypothesized to have several benefits. Additionally, there is evidence for more efficient gastric emptying in the right lateral position. In this multicenter RCT, we aimed to compare the effects of three-times-a-day gastric feeding while in the right lateral tilt position (intermittent postural feeding) versus standard continuous gastric feeding (standard feeding) on gastrointestinal intolerance and mortality among mechanically ventilated patients in ICU. METHODS: Adult ICU patients with gastric feeding tube in-situ and requiring invasive mechanical ventilation were randomized to either intermittent postural feeding group or to the standard feeding group. The feeding formula, target daily feed volume and posture turns were determined as per standard practice for all patients. Primary outcome was an incidence rate per 100 patient-days of gastrointestinal intolerance, a composite outcome of vomiting, diarrhea or constipation. Secondary outcomes were all-cause hospital mortality, gastrointestinal intolerance-free days, ventilator-free days, episodes of vomiting or diarrhea per patient, and mean diet volume ratio (diet received/diet prescribed). RESULTS: At five multidisciplinary ICUs, 120 mechanically ventilated, adult ICU patients (median age 65 years, 60% males) were randomly allocated to intermittent postural feeding (n = 61) and standard feeding (n = 59). The primary outcome did not differ between intermittent feeding arm versus standard arm (8.5, 95% confidence interval (CI): 5.9-11.8, versus 6.2, 95% CI: 4.1-9.1 per 100 patient-days; p = 0.23). Gastrointestinal intolerance-free days until day 14 were similar (6 [2-8] versus 5 [2-10]; p = 0.68) in both groups. Number of episodes per patient of vomiting, diarrhea, or constipation also did not differ in between groups. All-cause hospital mortality between intermittent feeding arm versus standard arm was 20% versus 31% (p = 0.17). There were no significant between-group differences in any of the other secondary outcomes. CONCLUSIONS: Intermittent gastric feeds delivered three-times-a-day while in the right lateral tilt position among mechanically ventilated patients was as well tolerated as the continuous enteral feeding. A definitive RCT to assess other clinically important outcomes is justified. TRIAL REGISTRATION: ACTRN12616000212459 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365526&isReview=true.

Psychological symptoms and health-related quality of life in intubated and non-intubated intensive care survivors: A multicentre, prospective observational cohort study.

Objective: To compare long-term psychological symptoms and health-related quality of life (HRQOL) in intubated versus non-intubated ICU survivors. Design: Prospective, multicentre observational cohort study. Setting: Four tertiary medical-surgical ICUs in Australia. Participants: Intubated and non-intubated adult ICU survivors. Main outcome measures: Primary outcomes: clinically significant psychological symptoms at 3- and 12-month follow-up using Post-Traumatic Stress Syndrome-14 for post-traumatic stress disorder; Depression, Anxiety Stress Scales-21 for depression, anxiety, and stress. Secondary outcomes: HRQOL, using EuroQol-5D-5L questionnaire. Results: Of the 133 ICU survivors, 54/116 (47 %) had at least one clinically significant psychological symptom (i.e., post-traumatic stress disorder, anxiety, depression, stress) at follow-up. Clinically significant scores for psychological symptoms were observed in 26 (39 %) versus 16 (32 %) at 3-months [odds ratio 1.4, 95 % confidence interval (0.66-3.13), p = 0.38]; 23 (37 %) versus 10 (31 %) at 12-months [odds ratio 1.3, 95 % confidence interval (0.53-3.31), p = 0.57] of intubated versus non-intubated survivors, respectively. Usual activities and mobility were the most commonly affected HRQOL dimension, with >30 % at 3 versus months and >20 % at 12-months of overall survivors reporting ≥ moderate problems. There was no difference between the groups in any of the EQ5D dimensions. Conclusions: Nearly one-in-two (47 %) of the intubated and non-intubated ICU survivors reported clinically significant psychological symptoms at 3 and 12-month follow-ups. Overall, more than 30 % at 3-months and over 20 % at 12-months of the survivors in both groups had moderate or worse problems with their usual activities and mobility. The presence of psychological symptoms and HRQOL impairments was similar between the groups.

Standard care versus individualized blood pressure targets among critically ill patients with shock: A multicenter feasibility and preliminary efficacy study.

PURPOSE: Emerging evidence suggests that minimizing mean perfusion pressure (MPP) deficit during vasopressor therapy for shock can potentially reduce adverse kidney-related outcomes in ICU. We assessed feasibility and preliminary efficacy of individualizing MPP targets based on patients' own pre-illness basal-MPP among vasopressor-treated patients with shock. MATERIAL AND METHODS: In this prospective before-and-after trial, 31 patients during the 'before'/observational phase and 31 patients during the 'after'/intervention phase were enrolled at two tertiary-level Australian ICUs. Feasibility endpoint was time-weighted average MPP-deficit during vasopressor therapy. Preliminary efficacy outcomes were new significant AKI, major adverse kidney events within 14 days (MAKE-14), and 90-day mortality. RESULTS: Patients in the after group had lower MPP-deficit (median 18%, [interquartile range [IQR]: 11-23] vs. 4%, [IQR: 2-9], p < 0.001) and lower incidence of new significant AKI (8/31 [26%] vs. 1/31 [3%], p = 0.01) than the before group. The between-group differences in MAKE-14 (9/31 [29%] vs. 4/31 [13%], p = 0.12) and 90-day mortality (6/31 [19%] vs. 2/31 [6%], p = 0.13) were not statistically significant. CONCLUSIONS: An individualized blood pressure target strategy during vasopressor therapy in ICU was feasible and appeared to be efficacious in this preliminary study. Testing this strategy in a larger randomized controlled trial is warranted. STUDY REGISTRATION: ACTRN12617001459314.

Delirium After Mechanical Ventilation in Intensive Care Units: The Cognitive and Psychosocial Assessment (CAPA) Study Protocol.

BACKGROUND: In the intensive care unit (ICU), critical illness delirium occurs in the context of multiple comorbidities, multi-organ failure, and invasive management techniques, such as mechanical ventilation, sedation, and lack of sleep. Delirium is characterized by an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. The long-term cognitive and psychosocial function of patients that experience delirium in the ICU is of crucial interest because preliminary data suggest a strong association between ICU-related delirium and long-term cognitive impairment. OBJECTIVE: The aim of this study is to explore the relationship between delirium in the ICU and adverse outcomes by following mechanically ventilated patients for one year following their discharge from the ICU and collecting data on their long-term cognition and psychosocial function. METHODS: This study will be conducted by enrolling patients in two tertiary ICUs in Australia. We aim to recruit 200 patients who have been mechanically ventilated for more than 24 hours. Data will be collected at the following three time points: (1) at discharge where they will be administered the Mini-Mental State Examination (MMSE); (2) at 6 months after discharge from the ICU discharge where the Impact of Events Scale Revised (IES-R) and the Telephone Inventory for Cognitive Status (TICS) tests will be administered; and (3) at 12 months after discharge from the ICU where the patients will be administered the TICS and IES-R tests, as well as the Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE). The IQCODE will be administered to their "person responsible" or the significant other of the patient. RESULTS: Long-term cognition and psychosocial function will be the primary outcome of this study. Mortality will also be investigated as a secondary outcome. Active enrollment will take place until the end of September 2016 and data collection will conclude at the end of September 2017. The analysis and results are expected to be available by March 2018. CONCLUSION: Delirium during mechanical ventilation has been linked to longer ICU and hospital stays, higher financial burdens, increased risks of long-term cognitive impairment (ie, dementia), poor functional outcomes and quality of life, and decreased survival. However, delirium during mechanical ventilation in the ICU is not well understood. This study will advance our knowledge of the comprehensive, long-term effects of delirium on cognitive and psychosocial function. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001116415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371216 (Archived by WebCite at http://www.webcitation.org/ 6nfDkGTcW).