Clonidine for preventing emergence agitation in infants (PREVENT AGITATION II): Protocol and statistical analysis plan.

BACKGROUND: Emergence agitation is a common clinical condition in children. Symptoms pertaining to the spectrum of early postoperative negative behavior typically occur upon emergence from anesthesia. Clonidine is an effective adjunctive agent for the prevention of emergence agitation in children, but evidence in the smallest age groups is sparse We aim to investigate the efficacy and safety of an intraoperative bolus of intravenous clonidine for preventing emergence agitation in children 3-12 months of age. METHODS: This is a randomized, placebo-controlled, double-blind trial. We will enroll 320 patients aged 3-12 months who have been scheduled for general anesthesia maintained with sevoflurane and opioid. The randomization is parallel and stratified by age group, sex, and site. The investigational medicinal product will be administered intravenously ~20 min before the anticipated end of the surgical procedure. The intervention is clonidine 3 µg/kg and placebo is isotonic saline in a corresponding volume. RESULTS: The primary outcome is the incidence of emergence agitation as assessed on the Watcha scale, that is, any Watcha score >2 during participants' stay in the postanesthetic care unit. Secondary outcomes are the proportion of participants with postoperative pain, with postoperative nausea and vomiting, and a composite safety outcome. Statistical analysis will be conducted according to the Statistical Analysis Plan with the intention-to-treat population for our primary analyses. CONCLUSION: The PREVENT AGITATION II trial will contribute valuable knowledge on efficacy for the prevention of emergence agitation and safety in infants.

Ventilation practices in burn patients-an international prospective observational cohort study.

BACKGROUND: It is unknown whether lung-protective ventilation is applied in burn patients and whether they benefit from it. This study aimed to determine ventilation practices in burn intensive care units (ICUs) and investigate the association between lung-protective ventilation and the number of ventilator-free days and alive at day 28 (VFD-28). METHODS: This is an international prospective observational cohort study including adult burn patients requiring mechanical ventilation. Low tidal volume (V T) was defined as V T ≤ 8 mL/kg predicted body weight (PBW). Levels of positive end-expiratory pressure (PEEP) and maximum airway pressures were collected. The association between V T and VFD-28 was analyzed using a competing risk model. Ventilation settings were presented for all patients, focusing on the first day of ventilation. We also compared ventilation settings between patients with and without inhalation trauma. RESULTS: A total of 160 patients from 28 ICUs in 16 countries were included. Low V T was used in 74% of patients, median V T size was 7.3 [interquartile range (IQR) 6.2-8.3] mL/kg PBW and did not differ between patients with and without inhalation trauma (p = 0.58). Median VFD-28 was 17 (IQR 0-26), without a difference between ventilation with low or high V T (p = 0.98). All patients were ventilated with PEEP levels ≥5 cmH2O; 80% of patients had maximum airway pressures <30 cmH2O. CONCLUSION: In this international cohort study we found that lung-protective ventilation is used in the majority of burn patients, irrespective of the presence of inhalation trauma. Use of low V T was not associated with a reduction in VFD-28. TRIAL REGISTRATION: Clinicaltrials.gov NCT02312869. Date of registration: 9 December 2014.

Inadequate follow-up after tracheostomy and intensive care.

INTRODUCTION: When patients are transferred from intensive care units (ICUs) to general wards with a tracheostomy in situ, there is a risk of suboptimal care and increased morbidity. The aim of this study was to elucidate the management of patients with a tracheostomy in situ at discharge from the ICU to the ward. MATERIAL AND METHODS: We performed an electronic questionnaire survey among heads of unit at registered Danish ICUs. RESULTS: A total of 34 out of 43 ICUs responded. 56% of the ICUs do not document individual plans for decannulation in the patient's chart. 91% of the ICUs do not perform daily follow-up of tracheotomised patients on the ward. No guidelines for decannulation on the ward were found, and only 6% have a guideline for accidental decannulation. Furthermore, as little as 47% of the ICUs report any formalized education or training of staff nurses in the management of tracheotomised patients. CONCLUSION: Guidelines relevant to patients discharged from Danish ICUs with a tracheal cannula in situ are scarce; few ICUs employ individualized plans for tracheostomy management and decannulation; there is largely no daily intensivist-led post-ICU follow-up, and formal staff education in tracheostomy management on the ward is scarce. Altogether these factors create a potential for adverse events and increased morbidity in this high-risk, high-cost patient population. Possibly individualized plans for tracheotomised patients as well as intensivist-led follow-up on the ward can improve patient outcome and safety and this should be confirmed in a future study. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.

BACKGROUND: Hydroxyethyl starch (HES) [corrected] is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. METHODS: In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization. RESULTS: Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P=0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P=0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline. CONCLUSIONS: Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.).

In-hospital resuscitation evaluated by in situ simulation: a prospective simulation study.

BACKGROUND: Interruption in chest compressions during cardiopulmonary resuscitation can be characterized as no flow ratio (NFR) and the importance of minimizing these pauses in chest compression has been highlighted recently. Further, documentation of resuscitation performance has been reported to be insufficient and there is a lack of identification of important issues where future efforts might be beneficial. By implementing in situ simulation we created a model to evaluate resuscitation performance. The aims of the study were to evaluate the feasibility of the applied method, and to examine differences in the resuscitation performance between the first responders and the cardiac arrest team. METHODS: A prospective observational study of 16 unannounced simulated cardiopulmonary arrest scenarios was conducted. The participants of the study involved all health care personel on duty who responded to a cardiac arrest. We measured NFR and time to detection of initial rhythm on defibrillator and performed a comparison between the first responders and the cardiac arrest team. RESULTS: Data from 13 out of 16 simulations was used to evaluate the ability of generating resuscitation performance data in simulated cardiac arrest. The defibrillator arrived after median 214 seconds (180-254) and detected initial rhythm after median 311 seconds (283-349). A significant difference in no flow ratio (NFR) was observed between the first responders, median NFR 38% (32-46), and the resuscitation teams, median NFR 25% (19-29), p < 0.001. The difference was significant even after adjusting for pulse and rhythm check and shock delivery. CONCLUSION: The main finding of this study was a significant difference between the first responders and the cardiac arrest team with the latter performing more adequate cardiopulmonary resuscitation with regards to NFR. Future research should focus on the educational potential for in-situ simulation in terms of improving skills of hospital staff and patient outcome.

Using e-learning for maintenance of ALS competence.

CONTEXT: A well-suited e-learning program might be a feasible strategy to maintain competence following a resuscitation course. AIM: This study had 2 aims: (1) to examine the effect of an e-learning program as a booster of competence acquired from an Advanced Life Support (ALS) course. (2) To identify factors related to the use of the e-learning program. MATERIALS AND METHODS: The study contained two parts pertaining to the two aims. The first part was a prospective single blinded randomised controlled study on junior doctors. The intervention was the monthly use of an e-learning program during one year and effect was measured as ALS-competence, a composite of a knowledge and skills test. The second part was a telephone interview of the intervention group. An interview guide was constructed based on existing knowledge of e-learning. In order to identify factors explaining the use of e-learning a univariate correlation was used to select significant variables to be included in a multiple regression analysis. RESULTS: Of the 134 invited to participate, 103 accepted the invitation. There were 79/103 (77%) participants, 40/51 in the intervention group and 39/52 in the control group. There was no difference between the groups with regards to ALS competence. Only 'social interaction' was an individually significant factor influencing the use of the e-learning program. CONCLUSIONS: This study did not demonstrate an effect of an e-learning program as a booster of competence acquired from an ALS course. The primary factor influencing the use of e-learning was the lack of social interaction.