Giorgio Della Rocca

Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial.

CONTEXT Tracheotomy is used to replace endotracheal intubation in patients requiring prolonged ventilation; however, there is considerable variability in the time considered optimal for performing tracheotomy. This is of clinical importance because timing is a key criterion for performing a tracheotomy and patients who receive one require a large amount of health care resources. OBJECTIVE To determine the effectiveness of early tracheotomy (after 6-8 days of laryngeal intubation) compared with late tracheotomy (after 13-15 days of laryngeal intubation) in reducing the incidence of pneumonia and increasing the number of ventilator-free and intensive care unit (ICU)-free days. DESIGN, SETTING, AND PATIENTS Randomized controlled trial performed in 12 Italian ICUs from June 2004 to June 2008 of 600 adult patients enrolled without lung infection, who had been ventilated for 24 hours, had a Simplified Acute Physiology Score II between 35 and 65, and had a sequential organ failure assessment score of 5 or greater. INTERVENTION Patients who had worsening of respiratory conditions, unchanged or worse sequential organ failure assessment score, and no pneumonia 48 hours after inclusion were randomized to early tracheotomy (n = 209; 145 received tracheotomy) or late tracheotomy (n = 210; 119 received tracheotomy). MAIN OUTCOME MEASURES The primary endpoint was incidence of ventilator-associated pneumonia; secondary endpoints during the 28 days immediately following randomization were number of ventilator-free days, number of ICU-free days, and number of patients in each group who were still alive. RESULTS Ventilator-associated pneumonia was observed in 30 patients in the early tracheotomy group (14%; 95% confidence interval [CI], 10%-19%) and in 44 patients in the late tracheotomy group (21%; 95% CI, 15%-26%) (P = .07). During the 28 days immediately following randomization, the hazard ratio of developing ventilator-associated pneumonia was 0.66 (95% CI, 0.42-1.04), remaining connected to the ventilator was 0.70 (95% CI, 0.56-0.87), remaining in the ICU was 0.73 (95% CI, 0.55-0.97), and dying was 0.80 (95% CI, 0.56-1.15). CONCLUSION Among mechanically ventilated adult ICU patients, early tracheotomy compared with late tracheotomy did not result in statistically significant improvement in incidence of ventilator-associated pneumonia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00262431.

Bench-to-bedside review: The importance of the precision of the reference technique in method comparison studies – with specific reference to the measurement of cardiac output

Bland-Altman analysis is used for assessing agreement between two measurements of the same clinical variable. In the field of cardiac output monitoring, its results, in terms of bias and limits of agreement, are often difficult to interpret, leading clinicians to use a cutoff of 30% in the percentage error in order to decide whether a new technique may be considered a good alternative. This percentage error of ± 30% arises from the assumption that the commonly used reference technique, intermittent thermodilution, has a precision of ± 20% or less. The combination of two precisions of ± 20% equates to a total error of ± 28.3%, which is commonly rounded up to ± 30%. Thus, finding a percentage error of less than ± 30% should equate to the new tested technique having an error similar to the reference, which therefore should be acceptable. In a worked example in this paper, we discuss the limitations of this approach, in particular in regard to the situation in which the reference technique may be either more or less precise than would normally be expected. This can lead to inappropriate conclusions being drawn from data acquired in validation studies of new monitoring technologies. We conclude that it is not acceptable to present comparison studies quoting percentage error as an acceptability criteria without reporting the precision of the reference technique.

Clinical review: Update on hemodynamic monitoring - a consensus of 16

Hemodynamic monitoring plays a fundamental role in the management of acutely ill patients. With increased concerns about the use of invasive techniques, notably the pulmonary artery catheter, to measure cardiac output, recent years have seen an influx of new, less-invasive means of measuring hemodynamic variables, leaving the clinician somewhat bewildered as to which technique, if any, is best and which he/she should use. In this consensus paper, we try to provide some clarification, offering an objective review of the available monitoring systems, including their specific advantages and limitations, and highlighting some key principles underlying hemodynamic monitoring in critically ill patients.

Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial

Background and objective Sugammadex, a modified γ-cyclodextrin, is a selective relaxant-binding agent designed to reverse the effects of the steroidal neuromuscular blocking agents rocuronium or vecuronium. This study compared the efficacy of sugammadex and neostigmine for reversal of neuromuscular blockade induced by rocuronium for facilitating elective surgery. Methods This randomised, multicentre, parallel-group trial included 98 adult patients. Patients received intravenous propofol for induction followed by sevoflurane maintenance anaesthesia. Neuromuscular blockade was monitored using acceleromyography and a train-of-four (TOF) mode of stimulation. Patients were randomly allocated to receive sugammadex 2.0 mg kg−1 or neostigmine 50 μg kg−1 (with glycopyrrolate 10 μg kg−1) at reappearance of the second response of the TOF (mean 16% twitch height of first response) after the last dose of rocuronium. Safety was evaluated by assessing adverse events, laboratory variables and vital signs. Results Time to recovery of the TOF ratio of 0.9 after sugammadex compared with neostigmine was significantly shorter (P < 0.0001), being 1.5 versus 18.6 min (geometric means). Predictability of response was greater with sugammadex than neostigmine: with 98% of sugammadex patients versus 11% of neostigmine patients recovering to a TOF ratio of 0.9 within 5 min. There were no clinical events related to residual neuromuscular blockade or reoccurrence of blockade. Serious adverse events were observed in two sugammadex-treated patients and in three neostigmine-treated patients, respectively, but none were considered related to study drugs. Conclusion Sugammadex achieved significantly faster recovery of neuromuscular function after rocuronium to a TOF ratio of 0.9 compared with neostigmine (Clinicaltrials.gov identifier: NCT00451217).

A balanced view of balanced solutions

The present review of fluid therapy studies using balanced solutions versus isotonic saline fluids (both crystalloids and colloids) aims to address recent controversy in this topic. The change to the acid-base equilibrium based on fluid selection is described. Key terms such as dilutional-hyperchloraemic acidosis (correctly used instead of dilutional acidosis or hyperchloraemic metabolic acidosis to account for both the Henderson-Hasselbalch and Stewart equations), isotonic saline and balanced solutions are defined. The review concludes that dilutional-hyperchloraemic acidosis is a side effect, mainly observed after the administration of large volumes of isotonic saline as a crystalloid. Its effect is moderate and relatively transient, and is minimised by limiting crystalloid administration through the use of colloids (in any carrier). Convincing evidence for clinically relevant adverse effects of dilutional-hyperchloraemic acidosis on renal function, coagulation, blood loss, the need for transfusion, gastrointestinal function or mortality cannot be found. In view of the long-term use of isotonic saline either as a crystalloid or as a colloid carrier, the paucity of data documenting detrimental effects of dilutional-hyperchloraemic acidosis and the limited published information on the effects of balanced solutions on outcome, we cannot currently recommend changing fluid therapy to the use of a balanced colloid preparation.

Cardiac output monitoring: aortic transpulmonary thermodilution and pulse contour analysis agree with standard thermodilution methods in patients undergoing lung transplantation.

PurposeThe PiCCO System is a relatively new device allowing intermittent cardiac output monitoring by aortic transpulmonary thermodilution technique (Aorta intermittent) and continuous cardiac output monitoring by pulse contour analysis (Aorta continuous). The objective of this study was to assess the level of agreement of Aorta intermittent and Aorta continuous with intermittent (PA intermittent) and continuous cardiac output (PA continuous) measured through a special pulmonary artery catheter (Vigilance System SvO2/CCO Monitor) in patients undergoing singleor double-lung transplantation.MethodsMeasurements were obtained in 58 patients: at four time points in patients undergoing single-lung transplantation and at six time points in those undergoing double-lung transplantation. Bland and Altman and correlation analyses were used for statistical evaluation.ResultsWe found close agreement between the techniques. Mean bias between Aorta intermittent and PA intermittent and between Aorta continuous and PA continuous was 0.18 L·min−1 (2SD of differences between methods = 1.59 L·min−1) and −0.07 L·min−1 (2SD of differences between methods = 1.46 L·min−1) respectively. Mean bias between PA continuous and PA intermittent and Aorta continuous and PA intermittent was 0.15 L·min−1 (2SD of differences between methods = 1.39 L·min−1) and 0.08 L·min−1 (2SD of differences between methods = 1.43 L·min−1).ConclusionMeasurements with the aortic transpulmonary thermodilution technique give continuous and intermittent values that agree with the pulmonary thermodilution method which is still the current clinical standard.RésuméObjectifLe PiCCO System est un appareil, relativement nouveau, de monitorage intermittent du débit cardiaque par la technique de thermodilution aortique transpulmonaire (aortique intermittente) et de monitorage continu du débit cardiaque par l’analyse de la conformation du pouls (aortique continue). L’objectif de l’étude était d’évaluer le degré de concordance entre la technique aortique intermittente et aortique continue, réalisée par la mesure du débit cardiaque intermittente (AP intermittente) et continue (AP continue) par un cathéter artériel pulmonaire spécial (Vigilance System SvO2/CCO Monitor) chez des patients qui subissent la greffe d’un ou des deux poumons.MéthodeLes mesures ont été prises à quatre moments déterminés chez 58 patients devant subir une greffe unipulmonaire et à six moments chez ceux qui devaient subir une greffe bipulmonaire. L’analyse de Bland et Altman et l’analyse de corrélation ont servi à l’évaluation statistique.RésultatsNous avons trouvé une étroite concordance entre les techniques. Le biais moyen entre la technique aortique intermittente et AP intermittente et entre Aortique continue et AP continue a été respectivement de 0,18 L·min−1 (différence de 2 écarts types entre les méthodes = 1,59 L·min−1 ) et − 0,07 L·min−1 (différence de 2 écarts types = 1,46 L·min−1 ). Le biais moyen entre AP continue et AP intermittente, et entre Aortique continue et Aortique intermittente a été de 0,15 L·min−1 (différence de 2 écarts types = 1,39 L·min−1) et 0,08 L·min−1 (différence de 2 écarts types =1,43 L·min−1 ).ConclusionLes mesures obtenues selon la technique de thermodilution aortique transpulmonaire ont fourni des valeurs continues et intermittentes qui concordent avec celle de la thermodilution pulmonaire, laquelle demeure la norme clinique.

Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia

IntroductionTotal hip replacement is one of the most commonly performed major orthopaedic operations. Goal-directed therapy (GDT) using haemodynamic monitoring has previously demonstrated outcome benefits in high-risk surgical patients under general anaesthesia. GDT has never been formally assessed during regional anaesthesia.MethodsPatients undergoing total hip replacement while under regional anaesthesia were randomised to either the control group (CTRL) or the protocol group (GDT). Patients in the GDT group, in addition to standard monitoring, were connected to the FloTrac sensor/Vigileo monitor haemodynamic monitoring system, and a GDT protocol was used to maximise the stroke volume and target the oxygen delivery index to > 600 mL/minute/m2.ResultsPatients randomised to the GDT group were given a greater volume of intravenous fluids during the intraoperative period (means ± standard deviation (SD): 6,032 ± 1,388 mL vs. 2,635 ± 346 mL; P < 0.0001), and more of the GDT patients received dobutamine (0 of 20 CTRL patients vs. 11 of 20 GDT patients; P < 0.0003). The GDT patients also received more blood transfused during the intraoperative period (means ± SD: 595 ± 316 mL vs. 0 ± 0 mL; P < 0.0001), although the CTRL group received greater volumes of blood replacement postoperatively (CTRL patients 658 ± 68 mL vs. GDT patients 198 ± 292 mL; P < 0.001). Overall blood consumption (intraoperatively and postoperatively) was not different between the two groups. There were an increased number of complications in the CTRL group (20 of 20 CTRL patients (100%) vs. 16 of 20 GDT patients (80%); P = 0.05). These outcomes were predominantly due to a difference in minor complications (20 of 20 CTRL patients (100%) vs. 15 of 20 GDT patients (75%); P = 0.047).ConclusionsGDT applied during regional anaesthesia in patients undergoing elective total hip replacement changes intraoperative fluid management and may improve patient outcomes by decreasing postoperative complications. Larger trials are required to confirm our findings.Trial registrationSRCTN11616985

Preload index: pulmonary artery occlusion pressure versus intrathoracic blood volume monitoring during lung transplantation.

UNLABELLED In this study, during lung transplantation, we analyzed a conventional preload index, the pulmonary artery occlusion pressure (PAOP), and a new preload index, the intrathoracic blood volume index (ITBVI), derived from the single-indicator transpulmonary dilution technique (PiCCO System), with respect to stroke volume index (SVIpa). We also evaluated the relationships between changes (Delta) in ITBVI and PAOP and DeltaSVIpa during lung transplantation. The reproducibility and precision of all cardiac index measurements obtained with the transpulmonary single-indicator dilution technique (CIart) and with the pulmonary artery thermodilution technique (CIpa) were also determined. Measurements were made in 50 patients monitored with a pulmonary artery catheter and with a PiCCO System at six stages throughout the study. Changes in the variables were calculated by subtracting the first from the second measurement (Delta(1)) and so on (Delta(1) to Delta(5)). The linear correlation between ITBVI and SVIpa was significant (r(2)=0.41; P < 0.0001), whereas PAOP poorly correlated with SVIpa (r(2) = -0.01). Changes in ITBVI correlated with changes in SVIpa (Delta(1), r(2) = 0.30; Delta(2), r(2) = 0.57; Delta(4), r(2) = 0.26; and Delta(5), r(2) = 0.67), whereas PAOP failed. The mean bias between CIart and CIpa was 0.15 l. min(-1). m(-2) (1.37). In conclusion, ITBVI is a valid indicator of cardiac preload and may be superior to PAOP in patients undergoing lung transplantation. IMPLICATIONS The assessment of intrathoracic blood volume index (ITBVI) by the transpulmonary single-indicator technique is a useful tool in lung transplant patients, providing a valid index of cardiac preload that may be superior to pulmonary artery occlusion pressure. However, more prospective, randomized studies are necessary to evaluate the role and limitations of this technique.

Thymectomy for myasthenia gravis: a 27-year experience

OBJECTIVE Thymectomy is considered an effective therapeutic option for patients with myasthenia gravis (MG). We reviewed our 27-year experience with surgical treatment of MG with respect to long-term results and factors affecting outcome. METHODS Between 1970 and 1997, we performed 232 thymectomies for MG. Fifteen patients were lost to follow-up; the remaining 217 form the object of our study. Sixty-two patients (28.4%) had thymoma. Myasthenia was graded according to a modified Osserman classification: 51 patients (23.5%) were in class I, 81(37.3%) in class IIA, 52 (24%) in class IIB, 26 (12%) in class III and seven (3.2%) in class IV. Mean duration of symptoms before the operation was 12+/-10 months. Fifty-eight thymectomies for thymoma were performed through a median sternotomy and four through a clamshell incision. Forty-six thymectomies for non-thymomatous MG were performed through a standard cervicotomy, 101 procedures through a partial upper sternal-splitting incision and eight through a complete median sternotomy. RESULTS Operative mortality was 0.92% (two patients). After a mean follow-up of 119 months, 71% of all patients improved their clinical status (25% without medications and asymptomatic; 46% with a reduction of medications and/or clinically improved); 39 (18%) have a stable disease with no clinical modifications; 12 (5%) presented a deterioration of their clinical status with worse symptoms, required more medications, or both. Thirteen patients (6%) died because of MG (mean survival 34.3+/-3.6 months). The presence of a thymoma negatively influenced the prognosis. Younger patients showed a more favorable outcome as well as patients with a shorter duration of symptoms before the operation; patients with lower classes of myasthenia showed a higher rate of remission. CONCLUSIONS Thymectomy is effective in the management of patients with MG at all stages with low morbidity. Patients with thymoma present a less favorable outcome.

Inhaled nitric oxide therapy in adults: European expert recommendations.

BackgroundInhaled nitric oxide (iNO) has been used for treatment of acute respiratory failure and pulmonary hypertension since 1991 in adult patients in the perioperative setting and in critical care.MethodsThis contribution assesses evidence for the use of iNO in this population as presented to a expert group jointly organised by the European Society of Intensive Care Medicine and the European Association of Cardiothoracic Anaesthesiologists.ConclusionsExpert recommendations on the use of iNO in adults were agreed on following presentation of the evidence at the expert meeting held in June 2004.