The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection tools

<p>Abstract</p> <p>Background</p> <p>Clinical trials evaluating the use of hypertonic saline in the treatment of hypovolemia and head trauma suggest no survival superiority over normal saline; however subgroup analyses suggest there may be a reduction in the inflammatory response and multiorgan failure which may lead to better survival and enhanced neurocognitive function. We describe a feasibility study of randomizing head injured patients to hypertonic saline and dextran vs. normal saline administration in the out of hospital setting.</p> <p>Methods/Design</p> <p>This feasibility study employs a randomized, placebo-controlled design evaluating normal saline compared with a single dose of 250 ml of 7.5% hypertonic saline in 6% dextran 70 in the management of traumatic brain injuries. The primary feasibility endpoints of the trial were: 1) baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial, 2) randomization compliance rate, 3) ease of protocol implementation in the out-of-hospital setting, and 4) adverse event rate of HSD infusion.</p> <p>The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.</p> <p>Discussion</p> <p>We anticipate three aspects of the trial will present challenges to trial success; ethical demands associated with a waiver of consent trial, challenging follow up and comprehensive accurate timely data collection of patient identifiers and clinical or laboratory values. In addition all the data collection tools had to be derived de novo as none existed in the literature.</p> <p>Trial registration number</p> <p>NCT00878631</p

Tracheostomy in mechanical ventilation

Endotracheal intubation is commonly used for airway control, while tracheostomy is a procedure indicated for patients who suffer from respiratory failure and need prolonged mechanical ventilation. Between 6% and 11% of mechanically ventilated patients receive a tracheostomy that allows for a lower sedation and shorter weaning time leading to a reduction in intensive care unit (ICU) and hospital stay. The technique and timing of tracheostomy are still controversial in the literature. Percutaneous dilational tracheostomy techniques, performed at the bedside in the ICU, are widely used, but there are still patients (with severe coagulation disorders or cervical spine injury) who can benefit from the surgical \u201cminimally invasive\u201d techniques. The correct timing is also under debate but, excluding patients with severe brain or cervical spine injury, we can reasonably affirm that tracheostomy should not be performed earlier than 2\u2005weeks following respiratory failure

Tracheostomy in mechanical ventilation

Endotracheal intubation is commonly used for airway control, while tracheostomy is a procedure indicated for patients who suffer from respiratory failure and need prolonged mechanical ventilation. Between 6% and 11% of mechanically ventilated patients receive a tracheostomy that allows for a lower sedation and shorter weaning time leading to a reduction in intensive care unit (ICU) and hospital stay. The technique and timing of tracheostomy are still controversial in the literature. Percutaneous dilational tracheostomy techniques, performed at the bedside in the ICU, are widely used, but there are still patients (with severe coagulation disorders or cervical spine injury) who can benefit from the surgical “minimally invasive” techniques. The correct timing is also under debate but, excluding patients with severe brain or cervical spine injury, we can reasonably affirm that tracheostomy should not be performed earlier than 2 weeks following respiratory failure

Sleep disturbances in the critically ill patients: role of delirium and sedative agents

BACKGROUND: Impairment of sleep quality and quantity has been described in critically ill patients. Delirium, an organ dysfunction that affects outcome of the critically ill patients, is characterized by an acute onset of impaired cognitive function, visual hallucinations, delusions, and illusions. These symptoms resemble the hypnagogic hallucinations and wakeful dreams seen in patients with neurological degenerative disorders and suffering of disorders of rapid eye movement (REM) sleep. We assessed the characteristics of sleep disruption in a cohort of surgical critically ill patients examining the hypothesis that severe impairments of rapid eyes movement (REM) sleep are associated to delirium. METHODS: Surgical patients admitted to the intensive care units of the San G. Battista Hospital (University of Turin) were enrolled. Once weaning was initiated, sleep was recorded for one night utilizing standard polysomnography. Clinical status, laboratory data on admission, co-morbidities and duration of mechanical ventilation were recorded. Patients were a priori classified as having a "severe REM reduction" or "REM reduction" if REM was higher or lower than 6% of the total sleep time (TST), respectively. Occurrence of delirium during intensive care unit (ICU) stay was identified by CAM-ICU twice a day. Multivariate forward stepwise logistic regression analysis was performed with sleep ("severe REM reduction" vs. "REM reduction") as the a priori dependent factor. RESULTS: REM sleep amounted to 44 (16-72) minutes [11 (8-55) % of the TST] in 14 patients ("REM reduction") and to 2.5 (0-36) minutes [1 (0-6) % of the TST] in the remaining 15 patients ("severe REM reduction") (P = 0.0004). SAPS II on admission was higher in " severely REM deprived" then in "REM deprived" patients. Delirium was present in 11 patients (73.3%) of the patients with "severe REM reduction" and lasted for a median of 3 (0-11) days before sleep assessment, while only one patient having "REM reduction" developed delirium that lasted for 1 day. The factors independently associated with a higher risk of developing "severe REM reduction" were delirium and daily dosage of lorazepam. CONCLUSION: The present study shows that while all critically ill patients present a profound fragmentation of sleep with a high frequency of arousals and awakenings and a reduction of REM sleep, a percentage of patients present an extremely severe reduction of REM sleep. Delirium and daily dosage of lorazepam are the factors independently associated to extremely severe REM sleep reduction

Combination antifungal treatment of pseudomembranous tracheobronchial invasive aspergillosis: A case report

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