M. Sesmu Arbous

Impact of Anesthesia Management Characteristics on Severe Morbidity and Mortality

Background: Quantitative estimates of how anesthesia management impacts perioperative morbidity and mortality are limited. The authors performed a study to identify risk factors related to anesthesia management for 24-h postoperative severe morbidity and mortality. Methods: A case-control study was performed of all patients undergoing anesthesia (1995-1997). Cases were patients who either remained comatose or died during or within 24 h of undergoing anesthesia. Controls were patients who neither remained comatose nor died during or within 24 hours of undergoing anesthesia. Data were collected by means of a questionnaire, the anesthesia and recovery form. Odds ratios were calculated for risk factors, adjusted for confounders. Results: The cohort comprised 869,483 patients; 807 cases and 883 controls were analyzed. The incidence of 24-h postoperative death was 8.8 (95% confidence interval, 8.2-9.5) per 10,000 anesthetics. The incidence of coma was 0.5 (95% confidence interval, 0.3-0.6). Anesthesia management factors that were statistically significantly associated with a decreased risk were: equipment check with protocol and checklist (odds ratio, 0.64), documentation of the equipment check (odds ratio, 0.61), a directly available anesthesiologist (odds ratio, 0.46), no change of anesthesiologist during anesthesia (odds ratio, 0.44), presence of a full-time working anesthetic nurse (odds ratio, 0.41), two persons present at emergence (odds ratio, 0.69), reversal of anesthesia (for muscle relaxants and the combination of muscle relaxants and opiates; odds ratios, 0.10 and 0.29, respectively), and postoperative pain medication as opposed to no pain medication, particularly if administered epidurally or intramuscularly as opposed to intravenously. Conclusions: Mortality after surgery is substantial and an association was established between perioperative coma and death and anesthesia management factors like intraoperative presence of anesthesia personnel, administration of drugs intraoperatively and postoperatively, and characteristics of delivered intraoperative and postoperative anesthetic care.

Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1.

ABSTRACT Complex Regional Pain Syndrome Type 1 (CRPS‐1) responds poorly to standard pain treatment. We evaluated if the N‐methyl‐d‐aspartate receptor antagonist S(+)‐ketamine improves pain in CRPS‐1 patients. Sixty CRPS‐1 patients (48 females) with severe pain participated in a double‐blind randomized placebo‐controlled parallel‐group trial. Patients were given a 4.2‐day intravenous infusion of low‐dose ketamine (n = 30) or placebo (n = 30) using an individualized stepwise tailoring of dosage based on effect (pain relief) and side effects (nausea/vomiting/psychomimetic effects). The primary outcome of the study was the pain score (numerical rating score: 0–10) during the 12‐week study period. The median (range) disease duration of the patients was 7.4 (0.1–31.9) years. At the end of infusion, the ketamine dose was 22.2 ± 2.0 mg/h/70 kg. Pain scores over the 12‐week study period in patients receiving ketamine were significantly lower than those in patients receiving placebo (P < 0.001). The lowest pain score was at the end of week 1: ketamine 2.68 ± 0.51, placebo 5.45 ± 0.48. In week 12, significance in pain relief between groups was lost (P = 0.07). Treatment did not cause functional improvement. Patients receiving ketamine more often experienced mild to moderate psychomimetic side effects during drug infusion (76% versus 18%, P < 0.001). In conclusion, in a population of mostly chronic CRPS‐1 patients with severe pain at baseline, a multiple day ketamine infusion resulted in significant pain relief without functional improvement. Treatment with ketamine was safe with psychomimetic side effects that were acceptable to most patients.

Mortality After Hospital Discharge in ICU Patients

Objectives:To assess the mortality risk of ICU patients after hospital discharge and compare it to mortality of the general Dutch population. Design:Cohort study of ICU admissions from a national ICU registry linked to administrative records from an insurance claims database. Setting:Eighty-one Dutch ICUs. Patients:ICU patients (n = 91,203) who were discharged alive from the hospital between January 1, 2007, and October 1, 2010. Interventions:None. Measurements and Main Results:The unadjusted observed survival was inspected by Kaplan-Meier curves. Mortality risk at 1, 2, and 3 years after hospital discharge was 12.5%, 19.3%, and 27.5%, respectively. The 3-year mortality after hospital discharge in ICU patients was higher than the weighted average of the gender and age-specific death risks of the general Dutch population (27.5% versus 8.2%). The 1-year mortality after hospital discharge was adjusted for case-mix differences by a set of determinants which showed a statistically significant influence on the outcome in a 10-fold cross validation. The elective and cardiac surgical patients have statistically significantly better mortality outcomes (adjusted hazard ratio, 0.73 and 0.28, respectively), whereas medical patients and patients admitted for cancer have statistically significantly worse mortality outcomes (adjusted hazard ratio, 1.41, 1.94, respectively) compared with other ICU patients. Urgent surgery patients and patients with a subarachnoid hemorrhage, trauma, acute renal failure, or severe community-acquired pneumonia did not differ statistically from the other ICU patients after adjustment for case-mix differences. Conclusions:In-hospital mortality underestimates the true mortality of ICU patients as the mortality in the first months after hospital discharge is substantial. Most ICU patients still have an increased mortality risk in the subsequent years after hospital discharge compared with the general Dutch population. The mortality after hospital discharge differs widely between ICU subgroups. Future studies should focus on the analysis of mortality after hospital discharge that is attributable to the former ICU admission.

Risk factors and outcomes after unplanned extubations on the ICU: a case-control study.

IntroductionUnplanned extubation (UE) is a frequent event during mechanical ventilation in critically ill patients and might be associated with increased morbidity and mortality. However, detailed knowledge of risk factors and outcomes after UE is lacking.MethodsA case-control study was performed with a case to control ratio of 1:4. Incidence density sampling was applied. Seventy-four cases and 296 control patients were included.ResultsSeventy-four UEs occurred in 69 patients, comprising 2% of all mechanically ventilated patients. Multivariable regression analysis revealed that the first and second categories of the Ramsay Sedation Scale score were associated with a high risk for an UE (odds ratios (ORs) 30 and 25, respectively). Male sex, subunit of the intensive care unit (ICU), length of stay in the ICU and midazolam use at time of UE were also risk factors for an UE. Patients with an UE had lower hospital mortality than mechanically ventilated patients without UE, 10% versus 30%, respectively. Forty-seven percent (n = 35) of the patients with an UE had to be reintubated.ConclusionsThe present study shows that the first and second categories of the Ramsay Sedation Scale were associated with a high risk for an UE. Also, male sex and use of midazolam at time of UE were identified as risk factors for an UE. However, compared with mechanically ventilated controls, no increased mortality was shown for UE patients. In UE patients without the need for subsequent reintubation, mortality was very low.

Transfusion of fresh-frozen plasma in critically ill patients with a coagulopathy before invasive procedures: a randomized clinical trial (CME).

Prophylactic use of fresh‐frozen plasma (FFP) is common practice in patients with a coagulopathy undergoing an invasive procedure. Evidence that FFP prevents bleeding is lacking, while risks of transfusion‐related morbidity after FFP have been well demonstrated. We aimed to assess whether omitting prophylactic FFP transfusion in nonbleeding critically ill patients with a coagulopathy who undergo an intervention is noninferior to a prophylactic transfusion of FFP.

Acute liver failure, multiorgan failure, cerebral oedema, and activation of proangiogenic and antiangiogenic factors in a case of Marburg haemorrhagic fever

A woman developed Marburg haemorrhagic fever in the Netherlands, most likely as a consequence of being exposed to virus-infected bats in the python cave in Maramagambo Forest during a visit to Uganda. The clinical syndrome was dominated by acute liver failure with secondary coagulopathy, followed by a severe systemic inflammatory response, multiorgan failure, and fatal cerebral oedema. A high blood viral load persisted during the course of the disease. The initial systemic inflammatory response coincided with peaks in interferon-γ and tumour necrosis factor-α concentrations in the blood. A terminal rise in interleukin-6, placental growth factor (PlGF), and soluble vascular endothelial growth factor receptor-1 (sVEGF-R1) seemed to suggest an advanced pathophysiological stage of Marburg haemorrhagic fever associated with vascular endothelial dysfunction and fatal cerebral oedema. The excess of circulating sVEGF-R1 and the high sVEGF-R1:PlGF ratio shortly before death resemble pathophysiological changes thought to play a causative part in pre-eclampsia. Aggressive critical-care treatment with renal replacement therapy and use of the molecular absorbent recirculation system appeared able to stabilise--at least temporarily--the patients condition.

Questionnaires on Family Satisfaction in the Adult ICU: A Systematic Review Including Psychometric Properties.

Objectives:To perform a systematic review of the literature to determine which questionnaires are currently available to measure family satisfaction with care on the ICU and to provide an overview of their quality by evaluating their psychometric properties. Data Sources:We searched PubMed, Embase, The Cochrane Library, Web of Science, PsycINFO, and CINAHL from inception to October 30, 2013. Study Selection:Experimental and observational research articles reporting on questionnaires on family satisfaction and/or needs in the ICU were included. Two reviewers determined eligibility. Data Extraction:Design, application mode, language, and the number of studies of the tools were registered. With this information, the tools were globally categorized according to validity and reliability: level I (well-established quality), II (approaching well-established quality), III (promising quality), or IV (unconfirmed quality). The quality of the highest level (I) tools was assessed by further examination of the psychometric properties and sample size of the studies. Data Synthesis:The search detected 3,655 references, from which 135 articles were included. We found 27 different tools that assessed overall or circumscribed aspects of family satisfaction with ICU care. Only four questionnaires were categorized as level I: the Critical Care Family Needs Inventory, the Society of Critical Care Medicine Family Needs Assessment, the Critical Care Family Satisfaction Survey, and the Family Satisfaction in the Intensive Care Unit. Studies on these questionnaires were of good sample size (n ≥ 100) and showed adequate data on face/content validity and internal consistency. Studies on the Critical Care Family Needs Inventory, the Family Satisfaction in the Intensive Care Unit also contained sufficient data on inter-rater/test-retest reliability, responsiveness, and feasibility. In general, data on measures of central tendency and sensitivity to change were scarce. Conclusions:Of all the questionnaires found, the Critical Care Family Needs Inventory and the Family Satisfaction in the Intensive Care Unit were the most reliable and valid in relation to their psychometric properties. However, a universal “best questionnaire” is indefinable because it depends on the specific goal, context, and population used in the inquiry.

Transfusion of fresh frozen plasma in non-bleeding ICU patients -TOPIC TRIAL: study protocol for a randomized controlled trial

BackgroundFresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients. With the aim to investigate whether prophylactic FFP transfusions to critically ill patients can be safely omitted, a multi-center randomized clinical trial is conducted in ICU patients with a coagulopathy undergoing an invasive procedure.MethodsA non-inferiority, prospective, multicenter randomized open-label, blinded end point evaluation (PROBE) trial. In the intervention group, a prophylactic transfusion of FFP prior to an invasive procedure is omitted compared to transfusion of a fixed dose of 12 ml/kg in the control group. Primary outcome measure is relevant bleeding. Secondary outcome measures are minor bleeding, correction of International Normalized Ratio, onset of acute lung injury, length of ventilation days and length of Intensive Care Unit stay.DiscussionThe Transfusion of Fresh Frozen Plasma in non-bleeding ICU patients (TOPIC) trial is the first multi-center randomized controlled trial powered to investigate whether it is safe to withhold FFP transfusion to coagulopathic critically ill patients undergoing an invasive procedure.Trial RegistrationTrial registration: Dutch Trial Register NTR2262 and ClinicalTrials.gov: NCT01143909

Incident and error reporting systems in intensive care: a systematic review of the literature.

PURPOSE We performed a systematic review to assess (i) to what extent incident reporting systems (IRSs) on the adult intensive care unit (ICU) meet the criteria of the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, (ii) to what extent the IRSs comply with the four aspects of the iterative quality loop and (iii) whether IRSs have led to improvement measures in clinical practice. DATA SOURCES The authors searched multiple electronic databases from 1966 until 26 June 2014. STUDY SELECTION Studies were included if they reported incident reporting systems on the adult ICU. DATA EXTRACTION Data on study design, characteristics of the incident reporting system, implementation, feedback and improvement measures were collected using structured data extraction forms. RESULTS OF DATA SYNTHESIS A total of 2098 studies were identified and 36 studies reported IRSs on the adult ICU. Studies were divided into: ICU-specific IRSs and general IRSs. Items of the WHO checklist were assessed and categorized into the four phases of the iterative quality loop. CONCLUSION None of the IRSs completely fulfilled the WHO checklist criteria. With respect to the iterative loop, data input and data collection are well established but not much attention was given to analyzing incidents and to give feedback. This resulted in an administrative report system, rather than the much desired instrument for change of practice and increase of quality as an IRS can only effectively contribute to improve patient safety and quality of care if more attention is given to analyzing incidents and feedback.

The epidural top-up: Predictors of increase of sensory blockade

Background Extension of sensory blockade after an epidural top-up in combined spinal epidural (CSE) anesthesia is partly attributed to compression of the dural sac by the injected volume. This study investigated whether a volume effect plays a significant role when administering an epidural top-up after an initial epidural loading dose and assessed the predictive value of different factors with respect to the increase in sensory blockade. Methods After an epidural loading dose of 75 mg ropivacaine, 0.75%, 30 patients were randomly assigned to one of three groups. After the maximum level of sensory blockade (MLSB) had been established, patients received either an epidural top-up with 10 ml ropivacaine, 0.75% (group 1, n = 10) or saline (group 2, n = 10), or no epidural top-up (group 3, n = 10). Subsequently, sensory blockade was assessed at 5-min intervals for a further 30 min by a blinded observer. Results The MLSB increased significantly in the patients receiving an epidural top-up with ropivacaine but not in the patients receiving normal saline. Sensory block extension was inversely related to the number of segments blocked at the time of the epidural top-up, and female gender was associated with a smaller increase in MLSB. Conclusions When using epidural ropivacaine, the extension of sensory blockade after administering an epidural top-up is caused by a local anesthetic effect and not by a volume effect. Under the conditions of this study, predictors of the increase in sensory blockade are the presence of ropivacaine in the top-up injectate, the number of segments blocked at the time of epidural top-up, and gender.