Acute liver failure requiring transplantation caused by ulipristal acetate.

Ulipristal has recently been suspected to be hepatotoxic by the European Medicines Agency but the evidence base for hepatotoxicity is sparse. This is a brief formal report of a patient administered ulipristal for 6-8 weeks and who developed acute liver failure leading to liver transplantation. The explanted liver showed extensive hepatocyte necrosis and inflammation compatible with drug-induced liver injury and cirrhosis. The usual causes of acute hepatitis and cirrhosis were eliminated. There were no other potential causative drugs. This case suggests that ulipristal may cause acute hepatitis, with pre-existing cirrhosis probably contributing to the severity of liver injury observed in this case. Ulipristal prescribers must remain vigilant and monitor liver function in their patients.

Postoperative Rehabilitation May Reduce the Risk of Readmission After Groin Hernia Repair.

Thirty-day readmission after surgery has been proposed as a quality-of-care indicator. We explored the effect of postoperative rehabilitation on readmission risk after groin hernia repair. We used the French National Discharge Database to identify all index hospitalizations for groin hernia repair in 2011. Readmissions within 30 days of discharge were clinically classified in terms of their relationship to the index stay. We used logistic regression to adjust the risk of readmission for patient, procedure and hospital factors. Among 122,952 index hospitalizations for inguinal hernia repair, 3,357 (2.7%) related 30-day readmissions were recorded. Reiterated analyses indicated that readmission risk was consistently associated with patient complexity: age (per year after 60 years, OR 1.03, 95% CI 1.02-1.03, P < 0.001), hospitalization within the previous year (OR 1.56, 95% CI 1.44-1.69, P < 0.001), and increasing severity and combination of co-morbidities. Postoperative rehabilitation was identified as a protective factor (OR 0.56, 95% CI 0.46-0.69, P < 0.001). Older patients and those with greater comorbidity are at elevated risk of readmission after inguinal hernia repair. Postoperative rehabilitation may reduce this risk. Further studies are warranted to confirm the protective effect of postoperative rehabilitation.

Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

BACKGROUND: Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. METHODS: We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. FINDINGS: Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). INTERPRETATION: Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared with usual sedation care. These findings support interruption of sedation in these patients following transfer from the operating room. FUNDING: Délégation à la Recherche Clinique et à l'Innovation du Groupement de Coopération Sanitaire de la Mission d'Enseignement, de Recherche, de Référence et d'Innovation (DRCI-GCS-MERRI) de Montpellier-Nîmes.

Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial.

PURPOSE: High-flow nasal cannula oxygen (HFNC) has the potential to provide apnoeic oxygenation. We decided to assess in a proof-of-concept study whether the addition of HFNC to non-invasive ventilation (NIV) could reduce oxygen desaturation during intubation, compared with NIV alone for preoxygenation, in severely hypoxaemic intensive care unit (ICU) patients with respiratory failure. METHODS: We conducted a randomised, controlled, single-centre trial with assessor-blinded outcome assessment in patients admitted to the ICU. Hypoxaemic patients requiring orotracheal intubation for respiratory failure were randomised to receive preoxygenation using HFNC [flow = 60 L/min, fraction of inspired oxygen (FiO2) = 100 %] combined with NIV (pressure support = 10 cmH2O, positive end-expiratory pressure = 5 cmH2O, FiO2 = 100 %) in the intervention group or NIV alone in the reference group prior to intubation. The primary outcome was the lowest oxygen saturation (SpO2) during the intubation procedure. Secondary outcomes were intubation-related complications and ICU mortality. RESULTS: Between July 2015 and February 2016, we randomly assigned 25 and 24 patients to the intervention and reference groups, respectively. In both groups the main reasons for respiratory failure were pneumonia and ARDS. During the intubation procedure, the lowest SpO2 values were significantly higher in the intervention group than in the reference group [100 (95-100) % vs. 96 (92-99) %, p = 0.029]. After exclusion of two patients from analysis for protocol violation, no (0 %) patients in the intervention group and five (21 %) patients in the reference group had SpO2 below 80 % (p = 0.050). We recorded no significant difference between the groups in intubation-related complications or ICU mortality. CONCLUSIONS: A novel strategy for preoxygenation in hypoxaemic patients, adding HFNC for apnoeic oxygenation to NIV prior to orotracheal intubation, may be more effective in reducing the severity of oxygen desaturation than the reference method using NIV alone.

Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA).

PURPOSE: High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap. METHODS: A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation. The primary endpoint was absolute risk reduction (ARR) for hypoxaemia at 1 h after extubation and after treatment discontinuation. Secondary outcomes included occurrence of postoperative pulmonary complications within 7 days after surgery, the duration of hospital stay, and in-hospital mortality. The analysis was performed on data from the modified intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT01887015). RESULTS: Between 6 November 2013 and 1 March 2015, 220 patients were randomly assigned to receive either HFNC (n = 108) or standard oxygen therapy (n = 112); all of these patients completed follow-up. The median duration of the allocated treatment was 16 h (interquartile range 14-18 h) with standard oxygen therapy and 15 h (interquartile range 12-18) with HFNC therapy. Twenty-three (21 %) of the 108 patients treated with HFNC 1 h after extubation and 29 (27 %) of the 108 patients after treatment discontinuation had postextubation hypoxaemia, compared with 27 (24 %) and 34 (30 %) of the 112 patients treated with standard oxygen (ARR 4, 95 % CI -8 to 15 %; p = 0.57; adjusted relative risk [RR] 0.87, 95 % CI 0.53-1.43; p = 0.58). Over the 7-day postoperative follow-up period, there was no statistically significant difference between the groups in the proportion of patients who remained free of any pulmonary complication (ARR 7, 95 % CI -6 to 20 %; p = 0.40). Other secondary outcomes also did not differ significantly between the two groups. CONCLUSIONS: Among patients undergoing major abdominal surgery, early preventive application of high-flow nasal cannula oxygen therapy after extubation did not result in improved pulmonary outcomes compared with standard oxygen therapy.

A simple widespread computer help improves nutrition support orders and decreases infection complications in critically ill patients.

AIMS: To assess the impact of a simple computer-based decision-support system (computer help) on the quality of nutrition support orders and patients' outcome in Intensive-Care Unit (ICU). METHODS: This quality-improvement study was carried out in a 16-bed medical-surgical ICU in a French university hospital. All consecutive patients who stayed in ICU more than 10 days with non-oral feeding for more than 5 days were retrospectively included during two 12-month periods. Prescriptions of nutrition support were collected and compared to French national guidelines as a quality-improvement process. A computer help was constructed using a simple Excel-sheet (Microsoft(TM)) to guide physicians' prescriptions according to guidelines. This computer help was displayed in computers previously used for medical orders. Physicians were informed but no systematic protocol was implemented. Patients included during the first (control group) and second period (computer help group) were compared for achievement of nutrition goals and ICU outcomes. RESULTS: The control and computer help groups respectively included 71 and 95 patients. Patients' characteristics were not significantly different between groups. In the computer help group, prescriptions achieved significantly more often 80% of nutrition goals for calorie (45% vs. 79% p<0.001) and nitrogen intake (3% vs. 37%, p<0.001). Incidence of nosocomial infections decreased significantly between the two groups (59% vs. 41%, p = 0.03). Mortality did not significantly differ between control (21%) and computer help groups (15%, p = 0.30). CONCLUSIONS: Use of a widespread inexpensive computer help is associated with significant improvements in nutrition support orders and decreased nosocomial infections in ICU patients. This computer-help is provided in electronic supplement.

[Respiratory preparation before surgery in patients with chronic respiratory failure]. / Préparation respiratoire préopératoire des patients insuffisants respiratoires chroniques.

Scheduled and/or thoracic, abdominal surgeries increase the risk of respiratory postoperative complications. In patients with chronic respiratory failure, preoperative evaluation should be performed to evaluate respiratory function in aim to optimize perioperative management. Preoperative gas exchange abnormalities (hypoxemia or hypercapnia) are associated with respiratory postoperative complications. Respiratory physiotherapy and prophylactic non-invasive ventilation should be integrated in a global rehabilitation management for cardiothoracic or abdominal surgery procedures, which are at high risk of postoperative respiratory dysfunction. Stopping tobacco consummation should be benefit, but decease risk of postoperative complications is relevant only after a period for 6 to 8 weeks of cessation. Bronchodilatator aerosol therapy (beta-agonists and atropinics) and inhaled corticotherapy allow a rapid preparation for 24 to 48 h. Systematic preoperative antibiotherapy should not be recommended.

The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study.

BACKGROUND: Noninvasive positive-pressure ventilation (NPPV) with pressure support-ventilation and positive end-expiratory pressure are effective in providing oxygenation during intubation in hypoxemic patients. We hypothesized administration of oxygen (O2) using NPPV would more rapidly increase the end-tidal O2 concentration (ETO2) than preoxygenation using spontaneous ventilation (SV) in morbidly obese patients. METHODS: Twenty-eight morbidly obese patients were enrolled in this prospective randomized study. Administration of O2 for 5 min was performed either with SV group or with NPPV (pressure support = 8 cm H2O, positive end-expiratory pressure = 6 cm H2O) (NPPV group). ETO2 was measured using the anesthesia breathing circuit, and is expressed as a fraction of atmospheric concentration. The primary end-point was the number of patients with an ETo(2) >95% at the end of O2 administration. Secondary end-points included the time to reach the maximal ETO2 and the ETO2 at the conclusion of O2 administration. RESULTS: A larger proportion of patients achieved a 95% ETO2 at 5 min with NPPV than SV (13/14 vs 7/14, P = 0.01). The time to reach the maximal ETO2 was significantly less in the NPPV than in the SV group (185 +/- 46 vs 222 +/- 42 s, P = 0.02). The mean ETO2 at the conclusion of O2 administration was larger in the NPPV group than the SV group (96.9 +/- 1.3 vs 94.1 +/- 2.0%, P < 0.001). A modest, although significant, increase in gastric distension was observed in the NPPV group. No adverse effects were observed in either group. CONCLUSION: Administration of O2 via a facemask with NPPV in the operating room is safe, feasible, and efficient in morbidly obese patients. In this population NPPV provides a more rapid O2 administration, achieving a higher ETO2.

Noninvasive positive pressure ventilation in patients with respiratory failure due to severe acute pancreatitis.

BACKGROUND: Patients with acute pancreatitis (AP) who require mechanical ventilation have high morbidity and mortality rates. Noninvasive positive pressure ventilation (NPPV) delivered through a mask has become increasingly popular for the treatment of acute respiratory failure (ARF) and may limit some mechanical ventilation complications. OBJECTIVES: The purpose of this retrospective, observational study was to evaluate our clinical experience with the use of NPPV in AP patients with ARF. METHODS: From 1997 to 2003, we documented clinical data, gas exchange and outcome of the 62 AP patients admitted to our intensive care unit. Patients who benefited from NPPV (success) were compared with those who failed (intubated). RESULTS: Twenty-nine patients were intubated at admission and 5 did not develop ARF. Of the 28 patients treated with NPPV, 15 were not intubated (54%). Both groups had a similar PaO(2)/FiO(2) ratio (142 +/- 21 vs. 133 +/- 20; p = 0.127) and severity of illness (Ranson and Balthazar scores). Presence of atelectasis, bilateral alveolar infiltrates and abdominal distension were associated with failure of NPPV. Oxygenation improved and respiratory rate decreased significantly only in the success group. Additionally, the length of stay at the intensive care unit was significantly lower in the success group. CONCLUSION: NPPV is feasible and safe to treat ARF in selected patients with AP who require ventilatory support.

Outcomes of patients with acute respiratory failure after abdominal surgery treated with noninvasive positive pressure ventilation.

OBJECTIVES: Little is known about the physiologic and clinical effects of noninvasive positive pressure ventilation (NPPV) in patients who have acute respiratory failure (ARF) after abdominal surgery. We evaluated our clinical experience with the use of NPPV in the treatment of ARF after abdominal surgery. METHODS: We prospectively evaluated NPPV use during a 2-year period in a medical-surgical ICU of a university hospital. We documented demographic and diagnostic data, gas exchange, and clinical outcomes. We compared patients who were not intubated to those who were intubated after a trial of NPPV. RESULTS: Of 72 patients with ARF after abdominal surgery who were treated with NPPV, 48 patients avoided intubation (67%). Patients in the intubated and nonintubated groups had similar demographic characteristics, and similar American Society of Anesthesiologists physical status and simplified acute physiology score II scores at admission. The intubated group had a significantly lower Pa(O2)/fraction of inspired oxygen (Fi(O2)) ratio (123 +/- 62 mm Hg vs 194 +/- 76 mm Hg, p < 0.01) and more extended bilateral alveolar infiltrates (67% vs 31%, p < 0.01) than the non-intubated group. Within the first NPPV observation period, the Pa(O2)/Fi(O2) increased (+ 36 +/- 29% [+/- SD], p = 0.04) and the respiratory rate decreased (28.2 +/- 3.4 breaths/min vs 23.1 +/- 3.8 breaths/min, p < 0.01) significantly only in the non-intubated group. The non-intubated group had significantly lower length of ICU stay (17.3 +/- 10.9 days vs 34.1 +/- 28.5 days, p < 0.01) and mortality rate (6% vs 29%, p < 0.01). CONCLUSION: NPPV may be an alternative to conventional ventilation in selected patients with ARF after abdominal surgery who require ventilatory support.

Volume-guaranteed pressure-support ventilation facing acute changes in ventilatory demand.

OBJECTIVE: To compare volume support ventilation (VSV) in which the pressure support level is continuously adjusted to deliver a preset tidal volume, with pressure support ventilation (PSV), in terms of patient behavior and ventilator response when ventilatory demand was increased by addition of dead space to the circuit. DESIGN AND SETTING: Randomized cross-over study in an intensive care unit university hospital. INTERVENTIONS: We assessed in ten patients being weaned off mechanical ventilation the effect of increasing the ventilatory demand by adding a heat-and-moisture exchanger to augment the dead space with a fixed level of PSV and VSV. MEASUREMENTS AND RESULTS: Arterial blood gases, breathing pattern, and respiratory effort parameters at the end of each of the four steps. Adding dead space significantly increased minute ventilation and PaCO2 values with both PSV and VSV. Indexes of respiratory effort (pressure-time index of respiratory muscles and work of breathing) increased with both ventilatory modes after dead-space augmentation. This increase was 2.5-4 times with VSV than with PSV and induced overt respiratory distress in two patients. The assistance delivered during VSV decreased significantly after dead-space augmentation, from 15.0+/-6.5 to 9.1+/-4.8 cmH2O, whereas no change occurred with PSV. CONCLUSIONS: With a fixed level of VSV, but not of PSV, an increase in ventilatory demand results in a decrease in the pressure support provided by the ventilator, opposite to the desired response. VSV may conceivably result in respiratory distress in clinical settings.