Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study.

BACKGROUND: Ventilator-associated pneumonia (VAP) is the most frequent health care-associated infection in severely ill patients, and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination. RESEARCH QUESTION: Is continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in patients with severe trauma? STUDY DESIGN AND METHODS: In this open-label, randomized controlled superiority trial conducted in 13 French ICUs, adults (age ≥ 18 years) with severe trauma (Injury Severity Score > 15) and requiring invasive mechanical ventilation for ≥ 48 h were enrolled. Patients were randomly assigned (1:1) via a secure Web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants. RESULTS: A total of 434 patients were recruited between July 31, 2015, and February 15, 2018, of whom 216 were assigned to the intervention group and 218 to the control group. Seventy-three patients (33.8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29.4%) in the control group (adjusted subdistribution hazard ratio, 0.96; 95% CI, 0.76-1.20; P = .71). No serious adverse events related to the use of the pneumatic device were noted. INTERPRETATION: Continuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in patients with severe trauma. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov.

Dexmedetomidine to facilitate non-invasive ventilation after blunt chest trauma: A randomised, double-blind, crossover, placebo-controlled pilot study.

BACKGROUND: Although non-invasive ventilation (NIV) is recommended in patients with chest trauma, this procedure may expose to discomfort and even failure due to agitation or excessive pain. We tested the impact of dexmedetomidine on the duration of the first session of NIV. METHODS: This randomised, crossover study enrolled 19 patients with blunt chest trauma who needed NIV. During one cycle comprising two NIV sessions, patients received in a random order an intravenous infusion of dexmedetomidine (0.7mcg/kg/h) and placebo (saline solution) that was initiated 60min prior to NIV. Dexmedetomidine (or placebo) was titrated to maintain a Richmond Agitation Sedation Scale (RASS) score between 0 and -3. A 6-h washout period was observed between NIV sessions. The reproducibility of the drug-related effects was tested during a second cycle of two NIV sessions. RESULTS: During the first cycle, dexmedetomidine prolonged the duration of NIV compared to placebo: 280min (118-450) (median, 25-75th quartiles) versus 120min (68-287) respectively, corresponding to a median increased duration of 96min (12-180) (P=0.03). Dexmedetomidine was associated with a lower score for RASS: -0.8 (-1.0;0.0) versus 0.0 (-0.5;0.0) (P<0.01), and reduced respiratory discomfort according to the 10cm visual similar scale: 0.6cm (0.0-3.0) versus 2.2cm (0.0-5.3) (P=0.05). Pain scores, morphine consumption, and blood gas measurements were comparable between groups. No difference in the duration of non-invasive ventilation was found during the second cycle. CONCLUSIONS: In this pilot trial, dexmedetomidine could facilitate the acceptance of the first session of non-invasive ventilation for patients with chest trauma.

Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol.

INTRODUCTION: Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients. METHODS AND ANALYSIS: This multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay. ETHICS AND DISSEMINATION: This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION: Clinical Trials NCT02534974.

A major trauma course based on posters, audio-guides and simulation improves the management skills of medical students: Evaluation via medical simulator.

BACKGROUND: Medical competence requires the acquisition of theoretical knowledge and technical skills. Severe trauma management teaching is poorly developed during internship. Nevertheless, the basics of major trauma management should be acquired by every future physician. For this reason, the major trauma course (MTC), an educational course in major traumatology, has been developed for medical students. Our objective was to evaluate, via a high fidelity medical simulator, the impact of the MTC on medical student skills concerning major trauma management. METHODS: The MTC contains 3 teaching modalities: posters with associated audio-guides, a procedural workshop on airway management and a teaching session using a medical simulator. Skills evaluation was performed 1 month before (step 1) and 1 month after (step 3) the MTC (step 2). Nineteen students were individually evaluated on 2 different major trauma scenarios. The primary endpoint was the difference between steps 1 and 3, in a combined score evaluating: admission, equipment, monitoring and safety (skill set 1) and systematic clinical examinations (skill set 2). RESULTS: After the course, the combined primary outcome score improved by 47% (P<0.01). Scenario choice or the order of use had no significant influence on the skill set evaluations. CONCLUSION: This study shows improvement in student skills for major trauma management, which we attribute mainly to the major trauma course developed in our institution.

Severe filamentous fungal infections after widespread tissue damage due to traumatic injury: six cases and review of the literature.

We describe 6 cases of severe filamentous fungal infections after widespread tissue damage due to traumatic injury in previously healthy people. Additionally, we report 69 cases from an exhaustive 20-y review of the literature to investigate the epidemiological and clinical features, the prognosis and the therapeutic management of these post-traumatic severe filamentous fungal infections. Traffic (41%) and farm accidents (25%) were the main causes of injury, which involved either the limbs only (41%) or multiple sites (41%). Necrosis was the main symptom (60%) and Mucorales (72%) and Aspergillus (11%) were the 2 most frequent fungi causing infection. These infections required substantial surgical debridement or amputation (96%) associated with aggressive antifungal therapy (81%), depending on the responsible fungi. This study underlines the need for early, repeated and systematic mycological wound samples to guide and adapt surgical and antifungal management in these filamentous fungal infections.

Equimolar doses of mannitol and hypertonic saline in the treatment of increased intracranial pressure.

OBJECTIVE: To compare the effects of equimolar doses of 20% mannitol solution and of 7.45% hypertonic saline solution (HSS) in the treatment of patients with sustained elevated intracranial pressure (ICP). DESIGN: Parallel, randomized, controlled trial. SETTING: Two intensive care units in a university hospital. PATIENTS: A total of 20 stable patients with a sustained ICP of >20 mm Hg secondary to traumatic brain injury (n = 17) or stroke (n = 3). INTERVENTIONS: A single equimolar infusion (255 mOsm dose) of either 231 mL of 20% mannitol (mannitol group; n = 10 patients) or 100 mL of 7.45% hypertonic saline (HSS group; n = 10 patients) during 20 mins of administration. MEASUREMENTS: ICP, arterial blood pressure, cerebral perfusion pressure, blood flow velocities of middle cerebral artery using continuous transcranial Doppler, brain tissue oxygen tension, serum sodium and osmolality, and urine output during a study period of 120 mins. MAIN RESULTS: The two treatments equally and durably reduced ICP during the experiment. At 60 mins after the start of the infusion, ICP was reduced by 45% +/- 19% of baseline values (mean +/- sd) in the mannitol group vs. 35% +/- 14% of baseline values in the HSS group. Cerebral perfusion pressure and diastolic and mean blood flow velocities were durably increased in the mannitol group, resulting in lower values of pulsatility index at the different times of the experiment (p < .01 vs. HSS). No major changes in brain tissue oxygen tension were found after each treatment. Mannitol caused a significantly greater increase in urine output (p < .05) than HSS, although there was no difference in the vascular filling requirement between the two treatments. HSS caused a significant elevation of serum sodium and chloride at 120 mins after the start of the infusion (p < .01). CONCLUSIONS: A single equimolar infusion of 20% mannitol is as effective as 7.45% HSS in decreasing ICP in patients with brain injury. Mannitol exerts additional effects on brain circulation through a possible improvement in blood rheology. Pretreatment factors, such as serum sodium, systemic hemodynamics, and brain hemodynamics, thus should be considered when choosing between mannitol and HSS for patients with increased ICP.