Spinal Cord Protection During Thoracic and Thoracoabdominal Endovascular Aortic Repair: 5-Year Results of a Preventive Protocol Including Prophylactic Cerebrospinal Fluid Drainage in High-Risk Patients.

PURPOSE: Spinal cord injury (SCI) is a devastating complication of thoracoabdominal aortic (TAA) repair. The use of prophylactic cerebrospinal fluid drainage (CSFD) as part of a protective protocol during endovascular repair is controversial. This article reports the results of the prophylactic use of CSFD as part of the of a prevention protocol implemented in 2016. METHODS: Retrospective review of spinal cord outcomes (SCI rate and CSFD-related complications) in patients treated endovascularly for TAA disease at a single institution from 2016 (implementation of an institutional SCI risk reduction protocol) to 2021. Patients were classified as high risk (≥2 factors), intermediate risk (1 factor), or low risk (0 factor). Only high-risk patients without contraindications underwent a prophylactic CSFD placement. RESULTS: One hundred eighty-one patients were analyzed (124 males; 69.6 years): 130 (69%) aneurysms (n=24 thoracic, n=28 Crawford 1-2-3, and n=78 Crawford 4/pararenal), 35 (19.9%) chronic aneurysmal dissections, and 16 (8.8%) acute complicated type B dissections. Interventions were staged in 31 (17.2%) cases, and consisted of 74 (41%) Thoracic EndoVascular Aneurysm Repair (TEVAR) and 107 (59%) Fenestrated Branched EndoVascular Aneurysm Repair (F-BEVAR). Sixty-nine (38.1%) patients were identified as being at high risk of SCI and CSFD was used prophylactically in 64 of them (4 failures and 1 contraindication). Spinal cord injury occurred in 8 cases (4 paraparesis, 4 paraplegias including 2 permanent), of which 3 had a prophylactic CSFD and 5 underwent rescue drainage. In addition, 4 patients developed SCI related to prophylactic CSFD (intradural hematoma), resulting in 1 paraparesis and 3 paraplegias. Other CSFD-related complications were mild (6) or moderate (2), for a total of 12 complications (17%). Factors associated with major drain complications were: curative anticoagulation 36 hours after drain removal (n=1), multiple punctures (n=1), platelet count <100 000 at drain removal (n=1), and bipolar disorder (n=2). Overall, 4 patients had permanent paraplegia and 1 had sphincter dysfunction at the last follow-up. Mean follow-up was 17 months. Mortality was 4.4% at 30 days and 13.3% at 18 months, including 3 (1.6%) aortic-related deaths. CONCLUSIONS: With the protocol we used to protect the spinal cord, we report results comparable with the SCI literature and highlight the risks associated with prophylactic CSFD use, which requires a better understanding of contraindications.

Risk Factors for Spinal Cord Injury during Endovascular Repair of Thoracoabdominal Aneurysm: Review of the Literature and Proposal of a Prognostic Score.

Despite recent improvements, spinal cord ischemia remains the most feared and dramatic complication following extensive aortic repair. Although endovascular procedures are associated with a lower risk compared with open procedures, this risk is still significant and must be considered. A combined medical and surgical approach may help to optimize the tolerance of the spinal cord to ischemia. The aim of this review is to describe the underlying mechanism involved in spinal cord injury during extensive endovascular aortic repair, to describe the different techniques used to improve spinal cord tolerance to ischemia-including the prophylactic or curative use of spinal drainage-and to propose our algorithm for spinal cord protection and the rational use of spinal drainage.

Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3).

BACKGROUND: The optimal calorie and protein intakes at the acute phase of severe critical illness remain unknown. We hypothesised that early calorie and protein restriction improved outcomes in these patients, compared with standard calorie and protein targets. METHODS: The pragmatic, randomised, controlled, multicentre, open-label, parallel-group NUTRIREA-3 trial was performed in 61 French intensive care units (ICUs). Adults (≥18 years) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned to early nutrition (started within 24 h after intubation) with either low or standard calorie and protein targets (6 kcal/kg per day and 0·2-0·4 g/kg per day protein vs 25 kcal/kg per day and 1·0-1·3 g/kg per day protein) during the first 7 ICU days. The two primary endpoints were time to readiness for ICU discharge and day 90 all-cause mortality. Key secondary outcomes included secondary infections, gastrointestinal events, and liver dysfunction. The trial is registered on ClinicalTrials.gov, NCT03573739, and is completed. FINDINGS: Of 3044 patients randomly assigned between July 5, 2018, and 8 Dec 8, 2020, eight withdrew consent to participation. By day 90, 628 (41·3%) of 1521 patients in the low group and 648 (42·8%) of 1515 patients in the standard group had died (absolute difference -1·5%, 95% CI -5·0 to 2·0; p=0·41). Median time to readiness for ICU discharge was 8·0 days (IQR 5·0-14·0) in the low group and 9·0 days (5·0-17·0) in the standard group (hazard ratio [HR] 1·12, 95% CI 1·02 to 1·22; p=0·015). Proportions of patients with secondary infections did not differ between the groups (HR 0·85, 0·71 to 1·01; p=0·06). The low group had lower proportions of patients with vomiting (HR 0·77, 0·67 to 0·89; p<0·001), diarrhoea (0·83, 0·73 to 0·94; p=0·004), bowel ischaemia (0·50, 0·26 to 0·95; p=0·030), and liver dysfunction (0·92, 0·86-0·99; p=0·032). INTERPRETATION: Compared with standard calorie and protein targets, early calorie and protein restriction did not decrease mortality but was associated with faster recovery and fewer complications. FUNDING: French Ministry of Health.

Fusion Imaging Guidance Does Not Affect Radiation Exposure During Endovascular Procedures for Lower Extremity Arterial Disease: A Randomized Controlled Trial.

PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.

Factors associated with acute mesenteric ischemia among critically ill ventilated patients with shock: a post hoc analysis of the NUTRIREA2 trial.

PURPOSE: Acute mesenteric ischemia (AMI) is a rare, but life-threatening condition occurring among critically ill patients. Several factors have been associated with AMI, but the causal link is debated, most studies being retrospective. Among these factors, enteral nutrition (EN) could be associated with AMI, in particular among patients with shock. We aimed to study the factors independently associated with AMI in a post hoc analysis of the NUTRIREA-2 trial including 2410 critically ill ventilated patients with shock, randomly assigned to receive EN or parenteral nutrition (PN). METHODS: Post hoc analysis of the NUTRIREA-2 trial was conducted. Ventilated adults with shock were randomly assigned to receive EN or PN. AMI was assessed by computed tomography, endoscopy, or laparotomy. Factors associated with AMI were studied by univariate and multivariate analysis. RESULTS: 2410 patients from 44 French intensive care units (ICUs) were included in the study: 1202 patients in the enteral group and 1208 patients in the parenteral group. The median age was 67 [58-76] years, with 67% men, a SAPS II score of 59 [46-74], and a medical cause for ICU admission in 92.7%. AMI was diagnosed among 24 (1%) patients, mainly by computed tomography (79%) or endoscopy (38%). The mechanism of AMI was non-occlusive mesenteric ischemia (n = 12), occlusive (n = 4), and indeterminate (n = 8). The median duration between inclusion in the trial and AMI diagnosis was 4 [1-11] days. Patients with AMI were older, had a higher SAPS II score at ICU admission, had higher plasma lactate, creatinine, and ASAT concentrations and lower hemoglobin concentration, had more frequently EN, dobutamine, and CVVHDF at inclusion, developed more frequently bacteremia during ICU stay, and had higher 28-day and 90-day mortality rates compared with patients without AMI. By multivariate analysis, AMI was independently associated with EN, dobutamine use, SAPS II score ≥ 62 and hemoglobin concentration ≤ 10.9 g/dL. CONCLUSION: Among critically ill ventilated patients with shock, EN, dobutamine use, SAPS II score ≥ 62 and hemoglobin ≤ 10.9 g/dL were independently associated with AMI. Among critically ill ventilated patients requiring vasopressors, EN should be delayed or introduced cautiously in case of low cardiac output requiring dobutamine and/or in case of multiple organ failure with high SAPS II score.

Single Centre Experience in Open and Endovascular Treatment of Renal Artery Aneurysms.

BACKGROUND: The true incidence and natural history of renal artery aneurysm (RAA) remain unclear and still exists controversy over indication for treatment. Several techniques of conventional surgical reconstructions are described in literature, and more recently endovascular therapies have been reported with satisfying results and lower complication rate. This paper aims to investigate the outcomes of both endovascular and open repair of RAA achieved in a single institution involving 3 medical teams (urology, vascular surgery and neuroradiology). MATERIAL AND METHODS: We conducted a single-centre retrospective observational study about all patients surgically or endovascularly treated for RAA over a 15-year period. Pre-operative, procedural and post-operative data at the early, mid- and long-term follow-up were collected and analysed, focusing on operative technique used for repair and related outcomes. RESULTS: A total of 27 patients (n = 17 (63%) women, mean age 58 ± 13.2, n = 26 saccular RAA) were included. Mean aneurysm was size was 18.8 ± 6.3 mm. Most diagnosis were accidental. Symptomatic RAA showed with macroscopic haematuria (n = 3, 25.9%), unstable hypertension (n = 2; 7%), chronic lumbar pain (n = 1, 3.7%) and renal infarct (n = 1, 3.7%). Conventional surgery (ex-vivo repair, aneurysmorraphy, aneurysm resection and end-to-end anastomosis) was performed in 14 (51.8%) cases and endovascular coiling embolization in 13 (48.2%). Mean hospital length of stay was 5.4 ± 3.6 days. Intensive Care Unit stay was needed only in the surgically treated patients (mean 1.1 ± 1.2 days). During the early follow-up, morbidity rate was 7/14 in surgically treated patients vs. 1/13 in endovascular group; it included bleeding, retroperitoneal hematoma, arterial thrombosis and bowel obstruction. The discharge imaging showed complete aneurysm exclusion and renal artery patency in all cases. At a mean follow-up of 39 ± 42 months, 3 patients (11%) were lost to follow up and 2 (7.4 %) died from unrelated cause. None of these patients required dialysis but a statistically significant (P = 0.09) decrease in GFR was noted between the preoperative period and last follow-up control. RAA repair neither showed blood pressure control improvement nor reduced the need for anti-hypertensive drug use. CONCLUSION: Open or endovascular techniques are both safe and efficient to treat RAA. Even though, surgical management is burdened with higher morbidity rate, the operative technique should be selected according to anatomical features, diameters and location of RRA; and the number of renal branches involved. Further larger studies are needed to define the feasibility and safety for a wider application of the endovascular approach.

Impact of early nutrition route in patients receiving extracorporeal membrane oxygenation: A retrospective cohort study.

BACKGROUND: Early nutrition management in patients receiving extracorporeal membrane oxygenation (ECMO) remains controversial. Despite its potentially beneficial effect, enteral nutrition (EN) could be associated with gastrointestinal (GI) complications. Total daily energy requirements remain difficult to achieve with ECMO support. Analysis of nutrition practices could improve nutrition management of this particular population. METHODS: A monocentric retrospective study of patients requiring ECMO in a cardiac surgery intensive care unit (ICU) between 2010 and 2014 with follow-up ≥6 days. Nutrition support was monitored daily until ECMO weaning. We compared patients exposed (EN group, n = 49) and unexposed (No EN group (NEN), n = 63) with EN, as well as the energy and protein intakes within 4 days after initiation of ECMO. Vital status and nosocomial infections were followed up until ICU discharge. Primary outcome was the incidence of GI intolerance and risk-factor identification. Secondary outcomes included impact of nutrition inadequacy and clinical outcome. RESULTS: A total 112 patients were analyzed, representing 969 nutrition days. Median ratio of energy and protein prescribed/required daily was 81% (58-113) and 56% (36-86), respectively. GI intolerance was experienced by 53% (26 of 49) of patients in the EN group and was only associated with ECMO duration (odds ratio, 1.14: 95% CI, 1.00-1.31; P = .05). Low-energy and protein days were not associated with clinical outcomes such as nosocomial infections. CONCLUSION: EN is associated with almost 50% GI intolerance without clinical benefit for patients receiving ECMO. Adequacy in energy and protein amounts did not affect clinical outcome.

Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3).

INTRODUCTION: International guidelines include early nutritional support (≤48 hour after admission), 20-25 kcal/kg/day, and 1.2-2 g/kg/day protein at the acute phase of critical illness. Recent data challenge the appropriateness of providing standard amounts of calories and protein during acute critical illness. Restricting calorie and protein intakes seemed beneficial, suggesting a role for metabolic pathways such as autophagy, a potential key mechanism in safeguarding cellular integrity, notably in the muscle, during critical illness. However, the optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding. We hypothesised that nutritional support with calorie and protein restriction during acute critical illness decreased day 90 mortality and/or dependency on intensive care unit (ICU) management in mechanically ventilated patients receiving vasoactive amine therapy for shock, compared with standard calorie and protein targets. METHODS AND ANALYSIS: NUTRIREA-3 is a randomised, controlled, multicentre, open-label trial comparing two parallel groups of patients receiving invasive mechanical ventilation and vasoactive amine therapy for shock and given early nutritional support according to one of two strategies: early calorie-protein restriction (6 kcal/kg/day-0.2-0.4 g/kg/day) or standard calorie-protein targets (25 kcal/kg/day, 1.0-1.3 g/kg/day) at the acute phase defined as the first 7 days in the ICU. We will include 3044 patients in 61 French ICUs. Two primary end-points will be evaluated: day 90 mortality and time to ICU discharge readiness. The trial will be considered positive if significant between-group differences are found for one or both alternative primary endpoints. Secondary outcomes include hospital-acquired infections and nutritional, clinical and functional outcomes. ETHICS AND DISSEMINATION: The NUTRIREA-3 study has been approved by the appropriate ethics committee. Patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03573739.

Automated Image Fusion Guidance during Endovascular Aorto-Iliac Procedures: A Randomized Controlled Pilot Study.

BACKGROUND: The benefits of imaging guidance using a new fully automated fusion process (CYDAR) have been demonstrated during endovascular aortic aneurysm repair, but little is known about its use during aorto-iliac occlusive disease endovascular revascularization. The aim of this study was to evaluate the influence of CYDAR image fusion guidance during endovascular treatment of symptomatic aorto-iliac occlusive lesions, compared with control patients treated using standard 2D fluoroscopy alone. METHODS: This is a single-center randomized controlled pilot study that recruited patients undergoing aorto-iliac endovascular revascularization. RESULTS: Between January 2019 and February 2020, 37 patients with symptomatic aorto-iliac lesions were enrolled: 18 were assigned to the fusion group and 19 to the control group. Patients and lesions characteristics were well balanced between both study groups. The technical success of the procedure was 100% in the Fusion group and 94% in the control group. All radiation-related parameters were lower in the fusion compared to the control group, including: median DAP 18.5 Gy.cm2 vs. 21.8 Gy.cm2; Air Kerma 0.10 Gy vs. 0.12 Gy; fluoroscopy dose 4.2 Gy.cm2 vs. 5.1 Gy.cm2; and number of DSA 7.5 vs. 8. The volume of iodinated contrast used was higher in the fusion group: 41 mL vs. 30 mL. The total procedure time was the same in both groups:60 min vs. 60 min. CONCLUSIONS: The results of this pilot study suggest the use of fusion imaging in endovascular treatment of aorto-iliac disease results in reduction in radiation-related measured parameters with no change in procedure time and higher doses of iodinated contrast used. These results need to be further investigated in a larger, adequately powered study.

Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2).

BACKGROUND: Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition. METHODS: In this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial) done at 44 French intensive-care units (ICUs), adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20-25 kcal/kg per day), within 24 h after intubation. Randomisation was stratified by centre using permutation blocks of variable sizes. Given that route of nutrition cannot be masked, blinding of the physicians and nurses was not feasible. Patients receiving parenteral nutrition could be switched to enteral nutrition after at least 72 h in the event of shock resolution (no vasopressor support for 24 consecutive hours and arterial lactate <2 mmol/L). The primary endpoint was mortality on day 28 after randomisation in the intention-to-treat-population. This study is registered with ClinicalTrials.gov, number NCT01802099. FINDINGS: After the second interim analysis, the independent Data Safety and Monitoring Board deemed that completing patient enrolment was unlikely to significantly change the results of the trial and recommended stopping patient recruitment. Between March 22, 2013, and June 30, 2015, 2410 patients were enrolled and randomly assigned; 1202 to the enteral group and 1208 to the parenteral group. By day 28, 443 (37%) of 1202 patients in the enteral group and 422 (35%) of 1208 patients in the parenteral group had died (absolute difference estimate 2·0%; [95% CI -1·9 to 5·8]; p=0·33). Cumulative incidence of patients with ICU-acquired infections did not differ between the enteral group (173 [14%]) and the parenteral group (194 [16%]; hazard ratio [HR] 0·89 [95% CI 0·72-1·09]; p=0·25). Compared with the parenteral group, the enteral group had higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1·89 [1·62-2·20]; p<0·0001), diarrhoea (432 [36%] vs 393 [33%]; 1·20 [1·05-1·37]; p=0·009), bowel ischaemia (19 [2%] vs five [<1%]; 3·84 [1·43-10·3]; p=0·007), and acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3·7 [1·03-13·2; p=0·04). INTERPRETATION: In critically ill adults with shock, early isocaloric enteral nutrition did not reduce mortality or the risk of secondary infections but was associated with a greater risk of digestive complications compared with early isocaloric parenteral nutrition. FUNDING: La Roche-sur-Yon Departmental Hospital and French Ministry of Health.

Speckle tracking analysis allows sensitive detection of stress cardiomyopathy in severe aneurysmal subarachnoid hemorrhage patients.

PURPOSE: Stress cardiomyopathy is a common life-threatening complication after aneurysmal subarachnoid hemorrhage (SAH). We hypothesized that left ventricular (LV) longitudinal strain alterations assessed with speckle tracking could identify early systolic function impairment. METHODS: This was an observational single-center prospective pilot controlled study conducted in a neuro-intensive care unit. Forty-six patients with severe SAH with a World Federation of Neurological Surgeons grade (WFNS) ≥ III were included. Transthoracic echocardiography (TTE) was performed on day 1, day 3, and day 7 after the patient's admission. A cardiologist blinded to the patient's management analyzed the LV global longitudinal strain (GLS). The control group comprised normal subjects matched according to gender and age. RESULTS: On day 1 median (25th-75th percentile) GLS was clearly impaired in SAH patients compared to controls [-16.7 (-18.7/-13.7) % versus -20 (-22/-19) %, p < 0.0001], whereas LVEF was preserved [65 (59-70) %]. GLS was severely impaired in patients with a WFNS score of V versus III-IV [-15.6 (-16.9/-12.3) % versus -17.8 (-20.6/-15.8) %, p = 0.008]. Seventeen (37 %) patients had a severe GLS alteration (>- 16 %). In these patients, GLS improved from day 1 [-12.4 (-14.8/-10.9) %] to last evaluation [-16.2 (-19/-14.6) %, p = 0.0007] in agreement with the natural evolution of stress cardiomyopathy. CONCLUSIONS: On the basis of LV GLS assessment, we demonstrated for the first time that myocardial alteration compatible with a stress cardiomyopathy is detectable in up to 37 % of patients with severe SAH while LVEF is preserved. GLS could be used for sensitive detection of stress cardiomyopathy. This is critical because cardiac impairment remains a major cause of morbidity and mortality after SAH.

Training experts in difficult airway management: Evaluation of a continuous professional development program.

OBJECTIVE: The Formation de référents aux techniques d'intubation difficile (FRTID) is a French continuing medical education program on difficult airway management. Its objectives are to train experts in the task of training other physicians in their hospitals for better guideline compliance. Our aim was to describe the curriculum of the experts and to evaluate the program's efficacy via a prospective survey. METHODS: Each participant was asked to complete a questionnaire before (T0), immediately (T1), 6 (T6) and 12 (T12) months after the course. The main criterion was the proportion of the participants who declared that they had implemented at least one action to improve difficult airway management in their institution at 6 months. Other criteria included the proportion of participants who declared that they had modified their own clinical practice and the frequency of use of specific devices assessed on modified Likert numerical rating scales. RESULTS: Two hundred and forty-four participants were included in the survey. One hundred and three, 91 and 62 participants responded to the T1 (immediately after the course), T6 (6 months later) and T12 (12 months later) questionnaires, respectively; 73 physicians (i.e. 30% of all participants and 80% of the survey responders) declared that they had implemented at least one action likely to optimize the management of difficult airways. On the T6 and T12 questionnaires, 91% and 97% of the responders respectively declared that they had changed their clinical practice. The course has resulted in increased use of transtracheal oxygenation with manual devices (Manujet(®), Enk(®)) and Seldinger cricothyroidotomy as well as paediatric difficult airway techniques such as paediatric sized elastic gum and Airtraq™ or fibrescopic intubation under general anaesthesia with spontaneous ventilation (through a laryngeal mask). CONCLUSION: These data encourage the training of experts in difficult airways. This curriculum is contributing to the dissemination of the recommendations among a large number of practitioners.

Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2).

BACKGROUND: Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock. METHODS/DESIGN: The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs. DISCUSSION: The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected to end in November 2015. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013).

Ultrasound-guided transversus abdominis plane/genitofemoral blocks for a patient receiving extracorporeal life support.

Extracorporeal life support may be used in patients with refractory cardiogenic shock. The femoral venoarterial route can be used for implanting cannulae in patients who are hemodynamically unstable. Here we describe the use of an ultrasound-guided transversus abdominis plane block supplemented with the femoral component of the genitofemoral nerve as the anesthesia technique for peripheral cannulation of the femoral vessels in a patient with severe acute heart failure after myocardial infarction with ST-segment elevation. The procedure was performed using 40 mL of a 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine (30 mL for transversus abdominis plane and 10 mL for genitofemoral block) associated with low-dose remifentanil infusion during spontaneous breathing. A left ventricular assist device was successfully implanted 4 days later.

What is the accuracy of the high-fidelity METI Human Patient Simulator physiological models during oxygen administration and apnea maneuvers?

BACKGROUND: A widely used physiological simulator is generally accepted to give valid predictions of oxygenation status during disturbances in breathing associated with anesthesia. We compared predicted measures with physiological measurements available in the literature, or derived from other models. METHODS: Five studies were selected from the literature which explored arterial oxygenation, with or without preoxygenation, in clinical situations or through mathematical modeling as well as the evolution of the fraction of expired oxygen (Feo2) during preoxygenation maneuvers. Scenarios from these studies were simulated on the METI-Human Patient Simulator™ simulator, and the data were compared with the results in the literature. RESULTS: Crash-induction anesthesia without preoxygenation induces an O2 pulse saturation (Spo2) decrease that is not observed on the METI simulator. In humans, after 8 minutes of apnea, Spo2 decreased below 90% while the worst value was 95% during the simulation. The apnea time to reach 85% was less with obese patients than with healthy simulated patients and was shortened in the absence of preoxygenation. However, the data in the literature include METI simulator confidence interval 95% values only for healthy humans receiving preoxygenation. The decrease in Pao2 during 35-second apnea started at end-expiration was slower on the METI simulator than the values reported in the literature. Feo2 evolution during preoxygenation maneuvers on the METI simulator with various inspired oxygen fractions (100%, 92%, 84%, and 68%) was very close to those reported in humans when perfect mask seal is provided. In practice, this seal is impossible to obtain on the METI simulator. CONCLUSIONS: Spo2 decreased much later during apnea on the METI simulator than in a clinical situation, whether preoxygenation was performed or not. The debriefing after simulation of critical situations or the use of the METI simulator to test a new equipment must consider these results.

Oxygen delivery during transtracheal oxygenation: a comparison of two manual devices.

BACKGROUND: The Manujet™ and the ENK Oxygen Flow Modulator™ (ENK) deliver oxygen during transtracheal oxygenation. We sought to describe the ventilation characteristics of these 2 devices. METHODS: The study was conducted in an artificial lung model consisting of a 15-cm ringed tube, simulating the trachea, connected via a flow analyzer and an artificial lung. A 15-gauge transtracheal wire reinforced catheter was used for transtracheal oxygenation. The ENK and Manujet were studied for 3 minutes at respiratory rates of 0, 4, and 12 breaths/min, with and without the artificial lung, in a totally and a partially occluded airway. Statistical analysis was performed using analysis of variance followed by a Fisher exact test; P < 0.05 was considered significant. RESULTS: Gas flow and tidal volume were 3 times greater with the Manujet than the ENK (approximately 37 vs 14 L · min(-1) and 700 vs 250 mL, respectively) and were not dependent on the respiratory rate. In the absence of ventilation, the ENK delivered a 0.6 ± 0.1 L · min(-1) constant gas flow. In the totally occluded airway, lung pressures increased to 136 cm H(2)O after 3 insufflations with the Manujet, whereas the ENK, which has a pressure release vent, generated acceptable pressures at a low respiratory rate (4 breaths/min) (peak pressure at 27.7 ± 0.7 and end-expiratory pressure at 18.8 ± 3.8 cm H(2)O). When used at a respiratory rate of 12 breaths/min, the ENK generated higher pressures (peak pressure at 95.9 ± 21.2 and end-expiratory pressure at 51.4 ± 21.4 cm H(2)O). In the partially occluded airway, lung pressures were significantly greater with the Manujet compared with the ENK, and pressures increased with the respiratory rate with both devices. Finally, the gas flow and tidal volume generated by the Manujet varied proportionally with the driving pressure. DISCUSSION: This study confirms the absolute necessity of allowing gas exhalation between 2 insufflations and maintaining low respiratory rates during transtracheal oxygenation. In the case of total airway obstruction, the ENK may be less deleterious because it has a pressure release vent. Using a Manujet at lower driving pressures may decrease the risk of barotrauma and allow the safe use of higher respiratory rates.