Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial.

BACKGROUND: Findings from preclinical studies and one pilot clinical trial suggest potential benefits of epidural analgesia in acute pancreatitis. We aimed to assess the efficacy of thoracic epidural analgesia, in addition to usual care, in improving clinical outcomes of intensive care unit patients with acute pancreatitis. METHODS: A multicenter, open-label, randomized, controlled trial including adult patients with a clinical diagnosis of acute pancreatitis upon admission to the intensive care unit. Participants were randomly assigned (1:1) to a strategy combining thoracic epidural analgesia and usual care (intervention group) or a strategy of usual care alone (control group). The primary outcome was the number of ventilator-free days from randomization until day 30. RESULTS: Between June 2014 and January 2019, 148 patients were enrolled, and 135 patients were included in the intention-to-treat analysis, with 65 patients randomly assigned to the intervention group and 70 to the control group. The number of ventilator-free days did not differ significantly between the intervention and control groups (median [interquartile range], 30 days [15-30] and 30 days [18-30], respectively; median absolute difference of - 0.0 days, 95% CI - 3.3 to 3.3; p = 0.59). Epidural analgesia was significantly associated with longer duration of invasive ventilation (median [interquartile range], 14 days [5-28] versus 6 days [2-13], p = 0.02). CONCLUSIONS: In a population of intensive care unit adults with acute pancreatitis and low requirement for intubation, this first multicenter randomized trial did not show the hypothesized benefit of epidural analgesia in addition to usual care. Safety of epidural analgesia in this setting requires further investigation. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT02126332 , April 30, 2014.

Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial.

BACKGROUND: Positive communication behaviour within anaesthesia teams may decrease stress response and improve clinical performance. We aimed to evaluate the effect of positive communication during medical handover on the subsequent team-based clinical performance in a simulated critical situation. We also assessed the effect of positive communication behaviour on stress response. METHODS: This single-centre RCT involved anaesthesia teams composed of a resident and a nurse in a high-fidelity scenario of anaesthesia-related paediatric laryngospasm after a standardised handover. During the handover, similar information was provided to all teams, but positive communication behaviour was adopted only for teams in the intervention group. Primary outcome was team-based clinical performance, assessed by an independent blinded observer, using video recordings and a 0-to 100-point scenario-specific scoring tool. Three categories of tasks were considered: safety checks before the incision, diagnosis/treatment of laryngospasm, and crisis resource management/non-technical skills. Individual stress response was monitored by perceived level of stress and HR variability. RESULTS: The clinical performance of 64 anaesthesia professionals (grouped into 32 teams) was analysed. The mean (standard deviation) team-based performance score in the intervention group was 44 (10) points vs 35 (12) in the control group (difference: +8.4; CI95% [0.4-16.4]; P=0.04). The effects were homogeneous over the three categories of tasks. Perceived level of stress and HR variability were not significantly different between groups. CONCLUSIONS: Positive communication behaviour between healthcare professionals during medical handover improved team-based performance in a simulation-based critical situation. CLINICAL TRIAL REGISTRATION: NCT03375073.

Impact of advance directives on the variability between intensivists in the decisions to forgo life-sustaining treatment.

BACKGROUND: There is wide variability between intensivists in the decisions to forgo life-sustaining treatment (DFLST). Advance directives (ADs) allow patients to communicate their end-of-life wishes to physicians. We assessed whether ADs reduced variability in DFLSTs between intensivists. METHODS: We conducted a multicenter, prospective, simulation study. Eight patients expressed their wishes in ADs after being informed about DFLSTs by an intensivist-investigator. The participating intensivists answered ten questions about the DFLSTs of each patient in two scenarios, referring to patients' characteristics without ADs (round 1) and then with (round 2). DFLST score ranged from 0 (no-DFLST) to 10 (DFLST for all questions). The main outcome was variability in DFLSTs between intensivists, expressed as relative standard deviation (RSD). RESULTS: A total of 19,680 decisions made by 123 intensivists from 27 ICUs were analyzed. The DFLST score was higher with ADs than without (6.02 95% CI [5.85; 6.19] vs 4.92 95% CI [4.75; 5.10], p < 0.001). High inter-intensivist variability did not change with ADs (RSD: 0.56 (round 1) vs 0.46 (round 2), p = 0.84). Inter-intensivist agreement on DFLSTs was weak with ADs (intra-class correlation coefficient: 0.28). No factor associated with DFLSTs was identified. A qualitative analysis of ADs showed focus on end-of-life wills, unwanted things and fear of pain. CONCLUSIONS: ADs increased the DFLST rate but did not reduce variability between the intensivists. In the decision-making process using ADs, the intensivist's decision took priority. Further research is needed to improve the matching of the physicians' decision with the patient's wishes. Trial registration ClinicalTrials.gov Identifier: NCT03013530. Registered 6 January 2017; https://clinicaltrials.gov/ct2/show/NCT03013530 .

Disagreement Between Clinicians and Score in Decision-Making Capacity of Critically Ill Patients.

OBJECTIVES: To compare the assessment of decision-making capacity of ICU patients by attending clinicians (physicians, nurses, and residents) with a capacity score measured by the Mini-Mental Status Examination, completed by Aid to Capacity Evaluation if necessary. The primary outcome was agreement between physicians' assessments and the score. Secondary outcomes were agreement between nurses' or residents' assessments and the score and identification of factors associated with disagreement. DESIGN: A 1-day prevalence study. SETTING: Nineteen ICUs in France. SUBJECTS: All patients hospitalized in the ICU on the study day and the attending clinicians. INTERVENTIONS: The decision-making capacity of patients was assessed by the attending clinicians and independently by an observer using the score. MEASUREMENTS AND MAIN RESULTS: A total of 206 patients were assessed by 213 attending clinicians (57 physicians, 97 nurses, and 59 residents). Physicians designated more patients as having decision-making capacity (n = 92/206 [45%]) than score (n = 34/206 [17%]; absolute difference 28% [95% CI, 20-37%]; p = 0.001). There was a high disagreement between assessments of all clinicians and score (Kappa coefficient 0.39 [95% CI, 0.29-0.50] for physicians; 0.39 [95% CI, 0.27-0.52] for nurses; and 0.46 [95% CI, 0.35-0.58] for residents). The main factor associated with disagreement was a Glasgow Coma Scale score between 10 and 15 (odds ratio, 2.92 [1.18-7.19], p = 0.02 for physicians; 4.97 [1.50-16.45], p = 0.01 for nurses; and 3.39 [1.12-10.29], p = 0.03 for residents) without differentiating between the Glasgow Coma Scale scores from 10 to 15. CONCLUSIONS: The decision-making capacity of ICU patients was largely overestimated by all attending clinicians as compared with a score. The main factor associated with disagreement was a Glasgow Coma Scale score between 10 and 15, suggesting that clinicians confused consciousness with decision-making capacity.

Epidural analgesia in critically ill patients with acute pancreatitis: the multicentre randomised controlled EPIPAN study protocol.

BACKGROUND: Acute pancreatitis (AP) is associated with high morbidity and mortality in its most severe forms. Most patients with severe AP require intubation and invasive mechanical ventilation, frequently for more than 7 days, which is associated with the worst outcome. Recent increasing evidence from preclinical and clinical studies support the beneficial effects of epidural analgesia (EA) in AP, such as increased gut barrier function and splanchnic, pancreatic and renal perfusion, decreased liver damage and inflammatory response, and reduced mortality. Because recent studies suggest that EA might be a safe procedure in the critically ill, we sought to determine whether EA reduced AP-associated respiratory failure and other major clinical outcomes in patients with AP. METHODS AND ANALYSIS: The Epidural Analgesia for Pancreatitis (EPIPAN) trial is an investigator-initiated, prospective, multicentre, randomised controlled two-arm trial with assessor-blinded outcome assessment. The EPIPAN trial will randomise 148 patients with AP requiring admission to an intensive care unit (ICU) to receive EA (with patient-controlled epidural administration of ropivacaine and sufentanil) combined with standard care based on current recommendations on the treatment of AP (interventional group), or standard care alone (reference group). The primary outcome is the number of ventilator-free days at day 30. Secondary outcomes include main complications of AP (eg, organ failure and mortality, among others), levels of biological markers of systemic inflammation, epithelial lung injury, renal failure, and healthcare-associated costs. ETHICS AND DISSEMINATION: The study was approved by the appropriate ethics committee (CPP Sud-Est VI). Informed consent is required. If the combined application of EA and standard care proves superior to standard care alone in patients with AP in the ICU, the use of EA may become standard practice in experienced centres, thereby decreasing potential complications related to AP and its burden in critically ill patients. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02126332.

Respective impact of no escalation of treatment, withholding and withdrawal of life-sustaining treatment on ICU patients' prognosis: a multicenter study of the Outcomerea Research Group.

PURPOSE: To assess the prevalence of decisions to forgo life-sustaining treatment (DFLST), the patients characteristics, and to estimate the impact of DFLST stages on mortality. METHODS: Observational study of a prospective database between 2005 and 2012 from 13 ICUs. DFLST were defined as follows: no escalation of treatment (stage 1), not to start or escalate treatment even if such treatment is considered in the future; withholding (stage 2), not to start or escalate necessary treatment; withdrawal (stage 3), to stop necessary treatment. The impact of daily DFLST stage on day-30 hospital mortality was tested with a discrete-time Cox's model and adjusted for admission severity and daily SOFA score. RESULTS: Of 10,080 patients, 1290 (13%) made DFLST. The highest DFLST stage during the ICU stay was no escalation of treatment in 339 (26%) patients, withholding in 502 (39%) patients, and withdrawal in 449 (35%) patients. Older patients, patients with at least one chronic disease, and patients with greater ICU severity were significantly more numerous in the DFLST group. Day-30 mortality was 13% for non-DFLST patients, 35% for no escalation of treatment, 75% for withholding, 93% for withdrawal. After adjustment, an increase in day-30 mortality was associated with withholding and withdrawal (hazard ratio 95% CI 5.93 [4.95-7.12] and 20.05 [15.58-25.79], P < 0.0001), but not with no escalation of treatment (HR 1.14 [0.91-1.44], P = 0.25). CONCLUSIONS: DFLST were made in 13% of ICU patients. Withholding, withdrawal, older age, more comorbidities, and higher severity of illness were associated with higher mortality. No escalation of treatment was not associated with increased mortality.

Point-of-care ultrasound in intensive care units: assessment of 1073 procedures in a multicentric, prospective, observational study.

OBJECTIVE: To describe current use and diagnostic and therapeutic impacts of point-of-care ultrasound (POCUS) in the intensive care unit (ICU). BACKGROUND: POCUS is of growing importance in the ICU. Several guidelines recommend its use for procedural guidance and diagnostic assessment. Nevertheless, its current use and clinical impact remain unknown. METHODS: Prospective multicentric study in 142 ICUs in France, Belgium, and Switzerland. All the POCUS procedures performed during a 24-h period were prospectively analyzed. Data regarding patient condition and the POCUS procedures were collected. Factors associated with diagnostic and therapeutic impacts were identified. RESULTS: Among 1954 patients hospitalized during the study period, 1073 (55%) POCUS/day were performed in 709 (36%) patients. POCUS served for diagnostic assessment in 932 (87%) cases and procedural guidance in 141 (13%) cases. Transthoracic echocardiography, lung ultrasound, and transcranial Doppler accounted for 51, 17, and 16% of procedures, respectively. Diagnostic and therapeutic impacts of diagnostic POCUS examinations were 84 and 69%, respectively. Ultrasound guidance was used in 54 and 15% of cases for central venous line and arterial catheter placement, respectively. Hemodynamic instability, emergency conditions, transthoracic echocardiography, and ultrasounds performed by certified intensivists themselves were independent factors affecting diagnostic or therapeutic impacts. CONCLUSIONS: With regard to guidelines, POCUS utilization for procedural guidance remains insufficient. In contrast, POCUS for diagnostic assessment is of extensive use. Its impact on both diagnosis and treatment of ICU patients seems critical. This study identified factors associated with an improved clinical value of POCUS.

Epidural analgesia in the intensive care unit: An observational series of 121 patients.

BACKGROUND: Epidural analgesia (EA) has been more investigated during the perioperative period than in the intensive care unit (ICU) setting. Recent studies support beneficial effects for EA beyond analgesia itself. However, data on feasibility and safety are still lacking in the ICU. Our goal was to assess the feasibility and practice of EA in ICU patients. METHODS: Multicentre observational study in 3 ICUs over a 10-month period. Goals were to report the incidence of EA-related complications and EA duration. All ICU patients receiving EA were included, whether EA was initiated in the ICU or elsewhere, e.g. in the operating room. Demographics, clinical and biological data were prospectively recorded. Epidural catheter tips were sent to the microbiology laboratory for culture. RESULTS: One hundred and twenty-one patients were included (mean age 60 years), with mean SOFA and median SAPS II scores of 3.2 and 32, respectively. Reasons for EA initiation included trauma (14%), postoperative pain management after major surgery (42%), and pancreatitis (31%). No EA-related neurologic complication was recorded, and one case of epidural abscess is discussed. No other EA-related infectious complications were observed. Median duration of EA was 11 days. Reasons for EA discontinuation included efficient analgesia without EA (60%) and accidental catheter removal (17%). 22% of epidural catheter cultures were positive for skin flora bacteria. CONCLUSION: EA seems feasible in the ICU. Its apparent safety should be further validated in larger cohorts, but these preliminary results may stimulate more interest in the assessment of potential benefits associated with EA in the ICU setting.

Outcome of acute mesenteric ischemia in the intensive care unit: a retrospective, multicenter study of 780 cases.

BACKGROUND: In the intensive care unit (ICU), the outcomes of patients with acute mesenteric ischemia (AMI) are poorly documented. This study aimed to determine the risk factors for death in ICU patients with AMI. METHODS: A retrospective, observational, non-interventional, multicenter study was conducted in 43 ICUs of 38 public institutions in France. From January 2008 to December 2013, all adult patients with a diagnosis of AMI during their hospitalization in ICU were included in a database. The diagnosis was confirmed by at least one of three procedures (computed tomography scan, gastrointestinal endoscopy, or upon surgery). To determine factors associated with ICU death, we established a logistic regression model. Recursive partitioning analysis was applied to construct a decision tree regarding risk factors and their interactions most critical to determining outcomes. RESULTS: The death rate of the 780 included patients was 58 %. Being older, having a higher sequential organ failure assessment (SOFA) severity score at diagnosis, and a plasma lactate concentration over 2.7 mmol/l at diagnosis were independent risk factors of ICU mortality. In contrast, having a prior history of peripheral vascular disease or an initial surgical treatment were independent protective factors against ICU mortality. Using age and SOFA severity score, we established an ICU mortality score at diagnosis based on the cutoffs provided by recursive partitioning analysis. Probability of survival was statistically different (p < 0.001) between patients with a score from 0 to 2 and those with a score of 3 and 4. CONCLUSION: Acute mesenteric ischemia in ICU patients was associated with a 58 % ICU death rate. Age and SOFA severity score at diagnosis were risk factors for mortality. Plasma lactate concentration over 2.7 mmol/l was also an independent risk factor, but values in the normal range did not exclude the diagnosis of AMI.

Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study.

BACKGROUND: Patient-ventilator asynchrony is common during noninvasive ventilation (NIV) with pressure support ventilation (PSV). We examined the effect of neurally adjusted ventilatory assist (NAVA) delivered through a facemask on synchronization in patients with acute respiratory failure (ARF). METHODS: This was a prospective, physiologic, crossover study of 13 patients with ARF (median Pa(O(2))/F(IO(2)), 196 [interquartile range (IQR), 142-225]) given two 30-min trials of NIV with PSV and NAVA in random order. Diaphragm electrical activity (EAdi), neural inspiratory time (T(In)), trigger delay (Td), asynchrony index (AI), arterial blood gas levels, and patient discomfort were recorded. RESULTS: There were significantly fewer asynchrony events during NAVA than during PSV (10 [IQR, 5-14] events vs 17 [IQR, 8-24] events, P = .017), and the occurrence of severe asynchrony (AI > 10%) was also less under NAVA (P = .027). Ineffective efforts and delayed cycling were significantly less with NAVA (P < .05 for both). NAVA was also associated with reduced Td (0 [IQR, 0-30] milliseconds vs 90 [IQR, 30-130] milliseconds, P < .001) and inspiratory time in excess (10 [IQR, 0-28] milliseconds vs 125 [IQR, 20-312] milliseconds, P < .001), but T(In) was similar under PSV and NAVA. The EAdi signal to its maximal value was higher during NAVA than during PSV ( P = .017). There were no significant differences in arterial blood gases or patient discomfort under PSV and NAVA. CONCLUSION: In view of specific experimental conditions, our comparison of PSV and NAVA indicated that NAVA significantly reduced severe patient-ventilator asynchrony and resulted in similar improvements in gas exchange during NIV for ARF. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01426178; URL: www.clinicaltrials.gov.