Jamal A. Alhashemi

Cardiac output monitoring: an integrative perspective.

Cardiac output monitoring in the critically ill patient is standard practice in order to ensure tissue oxygenation [1] and has been traditionally accomplished using the pulmonary artery catheter (PAC). In recent years, however, the value of PAC has been questioned with some suggesting that its use might not only be unnecessary but also potentially harmful [1]. This notion, together with the availability of new less invasive cardiac output measuring devices, has markedly decreased the widespread use of the PAC [2]. Today, various devices are available to measure or estimate cardiac output using different methods. Some of these less invasive devices track stroke volume (SV) continuously and provide dynamic indices of fluid responsiveness, others allow assessment of volumetric preload variables, and some also provide continuous measurement of central venous saturation via the use of proprietary catheters that are attached to the same monitor. All these variables — together with cardiac output — may result in an improved hemodynamic assessment of the critically ill patient. However, it is important to appreciate that each device has its inherent limitations and that no cardiac output monitoring device can change patient outcome unless its use is coupled with an intervention that by itself has been associated with improved patient outcomes. Therefore, the concept of hemodynamic optimization is increasingly recognized as a cornerstone in the management of critically ill patients and has been shown to be associated with improved outcome in the perioperative [3] and in the intensive care unit (ICU) [4] setting.

Outcome of reintubated patients after scheduled extubation

PURPOSE The main objective of study was to evaluate the outcome of patients who require reintubation after elective extubation. MATERIALS AND METHODS This is an observational, prospective cohort study including mechanically ventilated patients who passed successfully a spontaneous breathing trial. Patients were observed for 48 hours after extubation. During this time, reintubation or use of noninvasive positive pressure ventilation was considered as a failure. Reintubated patients were followed after the reintubation to register complications and outcome. RESULTS A total of 1,152 extubated patients were included in the analysis. Three hundred thirty-six patients (29%) met the criteria for extubation failure. Extubation failure was independently associated with mortality (odds ratio, 3.29; 95% confidence interval, 2.19-4.93). One hundred eighty patients (16% of overall cohort) required reintubation within 48 hours after extubation. Median time from extubation to reintubation was 13 hours (interquartile range, 6-24 hours). Reintubation was independently associated with mortality (odds ratio, 5.18; 95% confidence interval, 3.38-7.94; P < .001). Higher mortality of reintubated patients was due to the development of complications after the reintubation. CONCLUSIONS In a large cohort of scheduled extubated patients, one third of patients developed extubation failure, of whom half needed reintubation. Reintubation was associated with increased mortality due to the development of new complications after reintubation.

Thrombocytopenia in Critically Ill Patients Receiving Thromboprophylaxis: Frequency, Risk Factors, and Outcomes

BACKGROUND Thrombocytopenia is the most common hemostatic disorder in critically ill patients. The objective of this study was to describe the incidence, risk factors, and outcomes of thrombocytopenia in patients admitted to medical-surgical ICUs. METHODS Three thousand seven hundred forty-six patients in 67 centers were enrolled in a randomized trial in which unfractionated heparin was compared with low-molecular-weight heparin (LMWH) for thromboprophylaxis. Patients who had baseline platelet counts < 75 × 10(9)/L or severe coagulopathy at screening were excluded. We analyzed the risk of developing mild (100-149 × 10(9)/L), moderate (50-99 × 10(9)/L), and severe (< 50 × 109/L) thrombocytopenia during an ICU stay. We also assessed independent and time-varying predictors of thrombocytopenia and the effect of thrombocytopenia on major bleeding, transfusions, and death. RESULTS The incidences of mild, moderate, and severe thrombocytopenia were 15.3%, 5.1%, and 1.6%, respectively. The predictors of each category of thrombocytopenia were APACHE (Acute Physiology and Chronic Health Evaluation) II score, use of inotropes or vasopressors, and renal replacement therapy. The risk of moderate thrombocytopenia was lower in patients who received LMWH thromboprophylaxis but higher in surgical patients and in patients who had liver disease. Each category of thrombocytopenia was associated with subsequent bleeding and transfusions. Moderate and severe thrombocytopenia were associated with increased ICU and hospital mortality. CONCLUSION A high severity of illness, prior surgery, use of inotropes or vasopressors, renal replacement therapy, and liver dysfunction are associated with a higher risk of thrombocytopenia developing in the ICU, whereas LMWH thromboprophylaxis is associated with a lower risk. Patients who develop thrombocytopenia in the ICU are more likely to bleed, receive transfusions, and die.

Dexmedetomidine in combination with morphine PCA provides superior analgesia for shockwave lithotripsy

PurposeTo compare the analgesic effects of dexmedetomidine/morphine with those of tramadol/midazolam in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for urinary calculi.MethodsSixty patients were randomized to receive either dexmedetomidine 1 μg·kg−1 iv followed by 0.5 μg·kg−1·hr−1 infusion together with morphine patient-controlled analgesia [(PCA); 2 mg bolus, five minutes lockout, 2 mg·hr−1 infusion; (Group DEX)], or tramadol 1.5 mg·kg−1 pre-mixed with midazolam 30μg·kg−1 iv followed by tramadol PCA [20 mg bolus, five minute lockout, 20 mg·hr−1 infusion; (Group TRA)]. Pain was assessed at baseline and every 15 min thereafter. Patients’ and urologist’s satisfaction with analgesia and sedation were determined on a seven-point scale ranging from 1 (extremely dissatisfied) to 7 (extremely satisfied). Patient’s discharge time was also documented.ResultsVisual analogue scale scores over time were consistently lower in Group DEX compared with Group TRA (P = 0.001). Patients’ satisfaction with analgesia (5 ± 1 vs 4 ± 2, P = 0.012) and with sedation (6 ± 1 vs 5 ± 1, P = 0.020), and urologist’s satisfaction (6 ± 1 vs 4 ± 2, P = 0.001) were all higher amongst Group DEX patients compared with Group TRA. There was no difference between discharge times of patients in Group DEX compared with those in Group TRA [85 (60, 115) min vs 65 (40,95) min, P = 0.069].ConclusionDexmedetomidine in combination with morphine PCA provided better analgesia for ESWL and was associated with higher patients’ and urologist’s satisfaction when compared with a tramadol/midazolam PCA combination.RésuméObjectifComparer les effets analgésiques des dexmédétomidine/morphine combinées avec ceux d’un mélange tramadol/midazolam chez des patients qui subissent une lithotripsie extracorporelle par ondes de choc (LEOC) pour calculs urinaires.MéthodeSoixante patients ont été répartis au hasard dans le groupe DEX pour recevoir 1 μg·kg−1 de dexmédétomidine iv suivi d’une perfusion à 0,5 μg·kg−1·h−1 combinée à de la morphine en analgésie autocontrôlée (AAC); [bolus de 2 mg, une période réfractaire de cinq minutes, une perfusion de 2 mg·h−1] ou dans le groupe TRA recevant 1,5 mg·kg−1 de tramadol prémélangé avec 30 μg·kg−1 de midazolam iv suivi de tramadol en AAC [bolus de 20 mg, période réfractaire de cinq minutes, perfusion à 20 mg·h−1]. La douleur a été évaluée au départ et toutes les 15 min par la suite. Le degré de satisfaction des patients et de l’urologue concemant l’analgésie et la sédation a été évalué sur une échelle en sept points de 1 (très insatisfait) à 7 (très satisfait). Le moment du congé a été aussi noté.RésultatsLes scores de l’échelle visuelle analogique ont été constamment plus bas chez les patients du Groupe DEX comparé au Groupe TRA (P = 0,001). Le degré de satisfaction des patients face à l’analgésie (5 ± 1 vs 4 ± 2, P = 0,012) et à la sédation (6 ± 1 vs 5 ± 1, P = 0,020), et celui de l’urologue (6 ± 1 vs 4 ± 2, P = 0,001) ont été plus élevés parmi les patients du Groupe DEX. Les patients des deux groupes ont reçu leur congé selon des délais comparables: Groupe DEX comparé au Groupe TRA [85 (60, 115) min vs 65 (40,95) min, P = 0,069].ConclusionLa dexmédétomidine combinée à la morphine en AAC fournit une meilleure analgésie pour la LEOC, et est associée à un plus haut degré de satisfaction des patients et de l’urologue, que le mélange en AAC de tramadol/midazolam.

Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery.

PurposeTo compare the effects ofiv acetaminophen with those of oral ibuprofen with respect to postoperative pain control and morphine requirements in patients receiving morphine patient-controllediv analgesia (PCIA) after Cesarean delivery.MethodsForty-five term patients scheduled for Cesarean delivery were randomized to receive acetaminophen 1 giv every six hours plus oral placebo (group A) or ibuprofen 400 mgpo every six hours plusiv placebo (group I); the first dose of study drug was given 30 min preoperatively. Postoperatively, all patients received PCIA for 48 hr using morphine bolus dose 2 mgiv, lockout interval ten minutes, and no basal infusion. Visual analogue scale (VAS; 0 to 10) at rest and morphine requirements were recorded every hour for four hours then every four hours for a total of 48 hr postoperatively. Patient satisfaction was recorded on a ten-point scale (from 1 to 10) 48 hr postoperatively.ResultsVisual analogue scale scores decreased similarly in both groups over time, however, there were no differences between groups at any time during the study period (estimated marginal means: 1.4 ± SEM 0.2vs 1.9 ± SEM 0.2 for groups A and I, respectively,P = 0.124). Cumulative doses of postoperative morphine were 98 ± 37vs 93 ± 33 mg for groups A and I, respectively (P = 0.628). Patient satisfaction with analgesia was high in both groups (9 ± 1vs 9 ± 1,P = 0.93).ConclusionIntravenous acetaminophen is a reasonable alternative to oral ibuprofen as an adjunct to morphine patient-controlled analgesia after Cesarean delivery.RésuméObjectifComparer les effets de l’acétaminophène iv à ceux de l’ibuprofène par voie orale quant au soulagement de la douleur et à la consommation de morphine chez les patientes recevant de la morphine dans le cadre d’une analgésie iv contrôlée par le patient (AICP) après une césarienne.MéthodeQuarante-quatre patientes se présentant pour une césarienne ont reçu, de façon aléatoire, soit de l’acétaminophène 1 g iv toutes les six heures plus un placebo (groupe A), soit de l’ibuprofène 400 mg po toutes les six heures plus un placebo iv (groupe I), la première dose étant donnée 30 min avant la chirurgie. Après la chirurgie, toutes les patientes ont bénéficié d’une AICP avec morphine pendant 48 h, à la dose de 2 mg iv, avec un intervalle d’interdiction de dix minutes et aucune perfusion continue. On a noté les échelles visuelles-analogiques de douleur (EVA; 0 à 10) au repos et les besoins en morphine toutes les heures pendant quatre heures, puis toutes les quatre heures pour un total de 48 h suivant la chirurgie. La satisfaction des patientes a été évaluée selon une échelle à dix niveaux (de 1 à 10) après 48 h.RésultatsLes scores d’EVA ont diminué avec le temps de façon semblable dans les deux groupes. Toutefois, on n’a retrouvé de différences significatives entre les groupes à aucun moment (moyenne marginale estimée: 1,4 ± ETM 0,2 vs 1,9 ± ETM 0,2 pour les groupes A et I, respectivement, P = 0,124). Les doses cumulatives de morphine étaient de 98 ± 37 vs 93 ± 33 mg pour les groupes A and I, respectivement (P = 0,628). Le niveau de satisfaction était élevé dans les deux groupes (9 ± 1 vs 9 ± 1, P = 0,93).ConclusionL’acétaminophène par voie iv est une alternative acceptable à l’ibuprofène par voie orale comme adjuvant dans le cadre d’une analgésie à la morphine contrôlée par le patient.

The impact of time to tracheostomy on mechanical ventilation duration, length of stay, and mortality in intensive care unit patients

INTRODUCTION This study examined the potential effects of time to tracheostomy on mechanical ventilation duration, intensive care unit (ICU), and hospital length of stay (LOS), and ICU and hospital mortality. METHODS Cohort observational study was conducted in a tertiary care medical-surgical ICU based on a prospectively collected ICU database. We included 531 consecutive patients who were admitted between March 1999 and February 2005, and underwent tracheostomy during their ICU stay. The effect of time to tracheostomy on the different outcomes assessed was estimated using multivariate regression analyses (linear or logistic, based on the type of variables). Other independent variables that were included in the analyses included selected admission characteristics. RESULTS Mean +/- SD was 12.0 +/- 7.3 days for time to tracheostomy, and 23.1 +/- 18.9 days for ICU LOS. Time to tracheostomy was associated with an increased duration of mechanical ventilation (beta-coefficient = 1.31 for each day; 95% confidence interval [CI], 1.14-1.48), ICU LOS (beta-coefficient = 1.31 for each day; 95% CI, 1.13-1.48), and hospital LOS (beta-coefficient = 1.80 for each day; 95% CI, 0.65-2.94). On the other hand, time to tracheostomy was not associated with increased ICU or hospital mortality. CONCLUSIONS Time to tracheostomy was independently associated with increased mechanical ventilation duration, ICU LOS, and hospital LOS, but was not associated with increased mortality. Performing tracheostomy earlier in the course of ICU stay may have an effect on ICU resources and could entail significant cost-savings without adversely affecting patient mortality.

Anesthesiologist-controlled versus patient-controlled propofol sedation for shockwave lithotripsy

PurposeTo compare anesthesiologist-controlled sedation (ACS) with patient-controlled sedation (PCS), with respect to propofol requirements, sedation, and recovery, in patients undergoing extracorporeal shockwave lithotripsy for urinary calculi.MethodsSixty-four patients were randomized, in this doubleblind study, to receive propofol sedation according to one of two regimens: infusion of 200 μg·kg-1·min-1 for ten minutes reduced thereafter to 50-150 μg·kg-1·min-1 titrated by an anesthesiologist, according to patient response (group ACS), or propofol administered by patient-controlled analgesia (bolus dose 300 μg·kg-1, lockout interval three minutes, no basal infusion), (group PCS). All patients received midazolam 10 μg·kg-1 iv and fentanyl 1 μg·kg-1 iv preoperatively, followed by fentanyl infused at a rate of 0.5 μg·kg-1·hr-1 throughout the procedure. Sedation and analgesia were assessed using the A-line ARX index and visual analogue scale, respectively. Psychomotor recovery and readiness for recovery room discharge were assessed using the Trieger dot test and postanesthesia discharge score, respectively. Patient satisfaction was assessed on a sevenpoint scale (1-7).ResultsIn comparison to group PCS, patients in group ACS received more propofol (398 ± 162 mg vs 199 ± 68 mg, P < 0.001), were more sedated (A-line ARX index: 35 ± 16 vs 73 ± 16,P < 0.001), experienced less pain (visual analogue scale: 0 ± 0 vs 3 ± 1, P < 0.001), and were more satisfied (median [Q1, Q3]: 7 [7, 7] vs 6 [6, 7],P < 0.001). In contrast, patients in group PCS had faster psychomotor recovery (Trieger dot test median [Q1, Q3]: 8 [4, 16] vs 16 [12, 26] dots missed, P = 0.002) and achieved postanesthesia discharge score ≥ 9 earlier (median [Q1, Q3]: 40 [35, 60] vs 88 [75, 100] min,P < 0.001) compared with group ACS.ConclusionIn comparison to PCS for patients undergoing extracorporeal shockwave lithotripsy, propofol/fentanyl ACS is associated with increased propofol administration, deeper sedation levels, and greater patient comfort. However, ACS is associated with slower recovery and a longer time to meet discharge criteria, when compared to PCS.RésuméObjectifComparer la sédation contrôlée par ľanesthésiologiste (SCA) á la sédation contrôlée par le patient (SCP) quant aux demandes de propofol, á la sédation et á la récupération chez des patients devant subir une lithotripsie á ondes de choc électrohydraulique pour urolithiase.MéthodeSoixante-quatre patients, répartis au hasard pour une étude á double insu, ont reçu : soit une sédation par une perfusion de propofol de 200 μg·kg-1·min-1 pendant dix minutes, réduite ensuite á 50 -150 μg·kg-1·min-1 ajustée par un anesthésiologiste en fonction de la réaction du patient (groupe SCA), soit du propofol en analgésie autocontrôlée (bolus de 300 μg·kg-1, période réfractaire de trois minutes, sans perfusion initiale), (groupe SCP). Avant ľopération, tous les patients ont reçu 10μg·kg-1 de midazolam iv et 1 μg·kg-1 de fentanyl iv, puis une perfusion de fentanyl á 0,5 μg·kg-1·h-1 tout au long de ľintervention. La sédation et ľanalgésie ont été évaluées par ľindex A-line ARX et ľéchelle visuelle analogique (EVA), respectivement. La récupération psychomotrice et ľétat permettant de quitter la salle de réveil ont été évalués par le Trieger Dot Test et les critères de sortie de la salle de réveil, respectivement. La satisfaction du patient a été évaluée sur une échelle de sept points 1-7).RésultatsComparés aux patients du groupe SCP, ceux du groupe SCA ont reçu plus de propofol (398 ± 162 mg vs 199 ± 68 mg, P < 0,001), et plus de sédatifs (index A-line ARX : 35 ± 16 vs 73 ± 16, P < 0,001), éprouvé moins de douleur (EVA : 0 ± 0 vs 3 ± 1, P < 0,001) et ont été plus satisfaits (médiane [Q1, Q3] : 7 [7, 7] vs 6 [6, 7], P < 0,001). Par ailleurs, les patients du groupe SCP ont connu une récupération psychomotrice plus rapide (mé diane du Trieger dot test [Q1, Q3] : 8 [4, 16] vs 16 [12, 26] points manqués, P = 0,002) et ont atteint les critères de sortie de la salle de réveil ≥ 9 plus tôt (médiane [Q1, Q3] : 40 [35, 60] vs 88 [75, 100] min, P < 0,001).ConclusionComparée á la SCP pour une lithotripsie á ondes de choc électrohydraulique, la SCA au propofol/fentanyl est associée á une plus grande consommation de propofol, á des niveaux de sédation plus profonds et á un plus grand confort du patient. Mais la SCA, comparée á la SCP, retarde la récupération et prolonge le temps en salle de réveil.Objectif Comparer la sedation controlee par ľanesthesiologiste (SCA) a la sedation controlee par le patient (SCP) quant aux demandes de propofol, a la sedation et a la recuperation chez des patients devant subir une lithotripsie a ondes de choc electrohydraulique pour urolithiase.

Nonleg Venous Thrombosis in Critically Ill Adults: A Nested Prospective Cohort Study

IMPORTANCE Critically ill patients are at risk of venous thrombosis, and therefore guidelines recommend daily thromboprophylaxis. Deep vein thrombosis (DVT) commonly occurs in the lower extremities but can occur in other sites including the head and neck, trunk, and upper extremities. The risk of nonleg deep venous thromboses (NLDVTs), predisposing factors, and the association between NLDVTs and pulmonary embolism (PE) or death are unclear. OBJECTIVE To describe the frequency, anatomical location, risk factors, management, and consequences of NLDVTs in a large cohort of medical-surgical critically ill adults. DESIGN, SETTING, AND PARTICIPANTS A nested prospective cohort study in the setting of secondary and tertiary care intensive care units (ICUs). The study population comprised 3746 patients, who were expected to remain in the ICU for at least 3 days and were enrolled in a randomized clinical trial of dalteparin vs standard heparin for thromboprophylaxis. MAIN OUTCOMES AND MEASURES The proportion of patients who had NLDVTs, the mean number per patient, and the anatomical location. We characterized NLDVTs as prevalent or incident (identified within 72 hours of ICU admission or thereafter) and whether they were catheter related or not. We used multivariable regression models to evaluate risk factors for NLDVT and to examine subsequent anticoagulant therapy, associated PE, and death. RESULTS Of 3746 trial patients, 84 (2.2%) developed 1 or more non-leg vein thromboses (superficial or deep, proximal or distal). Thromboses were more commonly incident (n = 75 [2.0%]) than prevalent (n = 9 [0.2%]) (P < .001) and more often deep (n = 67 [1.8%]) than superficial (n = 31 [0.8%]) (P < .001). Cancer was the only independent predictor of incident NLDVT (hazard ratio [HR], 2.22; 95% CI, 1.06-4.65). After adjusting for Acute Physiology and Chronic Health Evaluation (APACHE) II scores, personal or family history of venous thromboembolism, body mass index, vasopressor use, type of thromboprophylaxis, and presence of leg DVT, NLDVTs were associated with an increased risk of PE (HR, 11.83; 95% CI, 4.80-29.18). Nonleg DVTs were not associated with ICU mortality (HR, 1.09; 95% CI, 0.62-1.92) in a model adjusting for age, APACHE II, vasopressor use, mechanical ventilation, renal replacement therapy, and platelet count below 50 × 10(9)/L. CONCLUSIONS AND RELEVANCE Despite universal heparin thromboprophylaxis, nonleg thromboses are found in 2.2% of medical-surgical critically ill patients, primarily in deep veins and proximal veins. Patients who have a malignant condition may have a significantly higher risk of developing NLDVT, and patients with NLDVT, compared with those without, appeared to be at higher risk of PE but not higher risk of death. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00182143.

La sédation au propofol contrôlée par ľanesthésiologiste ou le patient pour la lithotripsie par ondes de choc

PurposeTo compare anesthesiologist-controlled sedation (ACS) with patient-controlled sedation (PCS), with respect to propofol requirements, sedation, and recovery, in patients undergoing extracorporeal shockwave lithotripsy for urinary calculi.MethodsSixty-four patients were randomized, in this doubleblind study, to receive propofol sedation according to one of two regimens: infusion of 200 μg·kg-1·min-1 for ten minutes reduced thereafter to 50-150 μg·kg-1·min-1 titrated by an anesthesiologist, according to patient response (group ACS), or propofol administered by patient-controlled analgesia (bolus dose 300 μg·kg-1, lockout interval three minutes, no basal infusion), (group PCS). All patients received midazolam 10 μg·kg-1 iv and fentanyl 1 μg·kg-1 iv preoperatively, followed by fentanyl infused at a rate of 0.5 μg·kg-1·hr-1 throughout the procedure. Sedation and analgesia were assessed using the A-line ARX index and visual analogue scale, respectively. Psychomotor recovery and readiness for recovery room discharge were assessed using the Trieger dot test and postanesthesia discharge score, respectively. Patient satisfaction was assessed on a sevenpoint scale (1-7).ResultsIn comparison to group PCS, patients in group ACS received more propofol (398 ± 162 mg vs 199 ± 68 mg, P < 0.001), were more sedated (A-line ARX index: 35 ± 16 vs 73 ± 16,P < 0.001), experienced less pain (visual analogue scale: 0 ± 0 vs 3 ± 1, P < 0.001), and were more satisfied (median [Q1, Q3]: 7 [7, 7] vs 6 [6, 7],P < 0.001). In contrast, patients in group PCS had faster psychomotor recovery (Trieger dot test median [Q1, Q3]: 8 [4, 16] vs 16 [12, 26] dots missed, P = 0.002) and achieved postanesthesia discharge score ≥ 9 earlier (median [Q1, Q3]: 40 [35, 60] vs 88 [75, 100] min,P < 0.001) compared with group ACS.ConclusionIn comparison to PCS for patients undergoing extracorporeal shockwave lithotripsy, propofol/fentanyl ACS is associated with increased propofol administration, deeper sedation levels, and greater patient comfort. However, ACS is associated with slower recovery and a longer time to meet discharge criteria, when compared to PCS.RésuméObjectifComparer la sédation contrôlée par ľanesthésiologiste (SCA) á la sédation contrôlée par le patient (SCP) quant aux demandes de propofol, á la sédation et á la récupération chez des patients devant subir une lithotripsie á ondes de choc électrohydraulique pour urolithiase.MéthodeSoixante-quatre patients, répartis au hasard pour une étude á double insu, ont reçu : soit une sédation par une perfusion de propofol de 200 μg·kg-1·min-1 pendant dix minutes, réduite ensuite á 50 -150 μg·kg-1·min-1 ajustée par un anesthésiologiste en fonction de la réaction du patient (groupe SCA), soit du propofol en analgésie autocontrôlée (bolus de 300 μg·kg-1, période réfractaire de trois minutes, sans perfusion initiale), (groupe SCP). Avant ľopération, tous les patients ont reçu 10μg·kg-1 de midazolam iv et 1 μg·kg-1 de fentanyl iv, puis une perfusion de fentanyl á 0,5 μg·kg-1·h-1 tout au long de ľintervention. La sédation et ľanalgésie ont été évaluées par ľindex A-line ARX et ľéchelle visuelle analogique (EVA), respectivement. La récupération psychomotrice et ľétat permettant de quitter la salle de réveil ont été évalués par le Trieger Dot Test et les critères de sortie de la salle de réveil, respectivement. La satisfaction du patient a été évaluée sur une échelle de sept points 1-7).RésultatsComparés aux patients du groupe SCP, ceux du groupe SCA ont reçu plus de propofol (398 ± 162 mg vs 199 ± 68 mg, P < 0,001), et plus de sédatifs (index A-line ARX : 35 ± 16 vs 73 ± 16, P < 0,001), éprouvé moins de douleur (EVA : 0 ± 0 vs 3 ± 1, P < 0,001) et ont été plus satisfaits (médiane [Q1, Q3] : 7 [7, 7] vs 6 [6, 7], P < 0,001). Par ailleurs, les patients du groupe SCP ont connu une récupération psychomotrice plus rapide (mé diane du Trieger dot test [Q1, Q3] : 8 [4, 16] vs 16 [12, 26] points manqués, P = 0,002) et ont atteint les critères de sortie de la salle de réveil ≥ 9 plus tôt (médiane [Q1, Q3] : 40 [35, 60] vs 88 [75, 100] min, P < 0,001).ConclusionComparée á la SCP pour une lithotripsie á ondes de choc électrohydraulique, la SCA au propofol/fentanyl est associée á une plus grande consommation de propofol, á des niveaux de sédation plus profonds et á un plus grand confort du patient. Mais la SCA, comparée á la SCP, retarde la récupération et prolonge le temps en salle de réveil.Objectif Comparer la sedation controlee par ľanesthesiologiste (SCA) a la sedation controlee par le patient (SCP) quant aux demandes de propofol, a la sedation et a la recuperation chez des patients devant subir une lithotripsie a ondes de choc electrohydraulique pour urolithiase.

A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial

BackgroundSwine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes.Methods/DesignA multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration regimens, the proportion of primary and secondary endpoints collected, the number of patients receiving open-label statins, consent withdrawals and the effect of approved consent models on recruitment rates.DiscussionSeveral aspects of study design including the need to include central randomization, preserve allocation concealment, ensure study blinding compare to a matched placebo and the use novel consent models pose challenges to investigators conducting pandemic research. Moreover, study implementation requires that trial design be pragmatic and initiated in a short time period amidst uncertainty regarding the scope and duration of the pandemic.Trial Registration NumberISRCTN45190901