Intracranial pressure monitoring with and without brain tissue oxygen pressure monitoring for severe traumatic brain injury in France (OXY-TC): an open-label, randomised controlled superiority trial.

BACKGROUND: Optimisation of brain oxygenation might improve neurological outcome after traumatic brain injury. The OXY-TC trial explored the superiority of a strategy combining intracranial pressure and brain tissue oxygen pressure (PbtO2) monitoring over a strategy of intracranial pressure monitoring only to reduce the proportion of patients with poor neurological outcome at 6 months. METHODS: We did an open-label, randomised controlled superiority trial at 25 French tertiary referral centres. Within 16 h of brain injury, patients with severe traumatic brain injury (aged 18-75 years) were randomly assigned via a website to be managed during the first 5 days of admission to the intensive care unit either by intracranial pressure monitoring only or by both intracranial pressure and PbtO2 monitoring. Randomisation was stratified by age and centre. The study was open label due to the visibility of the intervention, but the statisticians and outcome assessors were masked to group allocation. The therapeutic objectives were to maintain intracranial pressure of 20 mm Hg or lower, and to keep PbtO2 (for those in the dual-monitoring group) above 20 mm Hg, at all times. The primary outcome was the proportion of patients with an extended Glasgow Outcome Scale (GOSE) score of 1-4 (death to upper severe disability) at 6 months after injury. The primary analysis was reported in the modified intention-to-treat population, which comprised all randomly assigned patients except those who withdrew consent or had protocol violations. This trial is registered with ClinicalTrials.gov, NCT02754063, and is completed. FINDINGS: Between June 15, 2016, and April 17, 2021, 318 patients were randomly assigned to receive either intracranial pressure monitoring only (n=160) or both intracranial pressure and PbtO2 monitoring (n=158). 27 individuals with protocol violations were not included in the modified intention-to-treat analysis. Thus, the primary outcome was analysed for 144 patients in the intracranial pressure only group and 147 patients in the intracranial pressure and PbtO2 group. Compared with intracranial pressure monitoring only, intracranial pressure and PbtO2 monitoring did not reduce the proportion of patients with GOSE score 1-4 (51% [95% CI 43-60] in the intracranial pressure monitoring only group vs 52% [43-60] in the intracranial pressure and PbtO2 monitoring group; odds ratio 1·0 [95% CI 0·6-1·7]; p=0·95). Two (1%) of 144 participants in the intracranial pressure only group and 12 (8%) of 147 participants in the intracranial pressure and PbtO2 group had catheter dysfunction (p=0.011). Six patients (4%) in the intracranial pressure and PbtO2 group had an intracrebral haematoma related to the catheter, compared with none in the intracranial pressure only group (p=0.030). No significant difference in deaths was found between the two groups at 12 months after injury. At 12 months, 33 deaths had occurred in the intracranial pressure group: 25 (76%) were attributable to the brain trauma, six (18%) were end-of-life decisions, and two (6%) due to sepsis. 34 deaths had occured in the intracranial pressure and PbtO2 group at 12 months: 25 (74%) were attributable to the brain trauma, six (18%) were end-of-life decisions, one (3%) due to pulmonary embolism, one (3%) due to haemorrhagic shock, and one (3%) due to cardiac arrest. INTERPRETATION: After severe non-penetrating traumatic brain injury, intracranial pressure and PbtO2 monitoring did not reduce the proportion of patients with poor neurological outcome at 6 months. Technical failures related to intracerebral catheter and intracerebral haematoma were more frequent in the intracranial pressure and PbtO2 group. Further research is needed to assess whether a targeted approach to multimodal brain monitoring could be useful in subgroups of patients with severe traumatic brain injury-eg, those with high intracranial pressure on admission. FUNDING: The French National Program for Clinical Research, La Fondation des Gueules Cassées, and Integra Lifesciences.

Warning Signs: Occult Diabetes and Dysglycemia in the Hand Surgery Patient Population.

BACKGROUND: Diabetes mellitus often exists for many years prior to diagnosis, and very little is known about the role of the prediagnosis stage of metabolic impairment in contributing to hand and upper-extremity pathology. The goal of this study is to determine the prevalence of undiagnosed glucose dysregulation in patients presenting with the 2 most commonly treated conditions of the hand and wrist. METHODS: A retrospective study was performed of hand surgery patients with no established diagnosis of prediabetes or diabetes referred for a 2-hour glucose tolerance test according to American Diabetes Association criteria. Patients were divided into 3 groups: peripheral neuropathies, trigger finger, and controls with various upper-extremity diagnoses. Rates of undiagnosed prediabetes and diabetes were compared between groups, including subgroup analysis of patients based on unilateral or bilateral presentation. Binary logistic regression analysis was also used to calculate odds ratios for multiple variables. RESULTS: Patients with neuropathy had a significantly higher incidence of undiagnosed dysglycemia compared with the control group. Of those patients, 51.3% were prediabetic and 12.8% were diabetic. The control group had significantly lower rates. Within the bilateral neuropathy patients, 59.6% had prediabetes and 15.4% had diabetes, versus 34.6% with prediabetes and 7.7% with diabetes in the unilateral group. CONCLUSIONS: Hand surgeons encounter a patient population with high rates of undiagnosed prediabetes and diabetes, with some presentations as much as 6 times higher than the general population. Certain patient presentations should prompt appropriate diagnostic testing and referral, especially those presenting with bilateral compression neuropathy and elevated body mass index.

Data Analysis of Plastic Surgery Instrument Trays Yields Significant Cost Savings and Efficiency Gains.

PURPOSE: Inpatient surgery costs have risen 30% over the past 5 years, and the operating room accounts for up to 60% of total hospital operational expense. On average, only 13.0% to 21.9% of instruments opened for a case are used, contributing to significant avoidable reprocessing, repurchase, and labor expense. METHODS: A comprehensive review of 40 major instrument trays at UNC Rex Hospital was conducted using a technology service (OpFlow; Operative Flow Technologies, Raleigh, NC). Among the full scope of the project, the general plastics tray and breast reconstruction tray were evaluated for the plastic surgery service line over a 3-month period. Intraoperative data collection was performed on the exact instruments used across a standard breadth of cases. Data analytics were conducted stratifying instrument usage concordance among surgeons by tray and procedure type. After a surgeon-led review of the proposed new tray configurations, the optimized versions were implemented via a methodical change management process. RESULTS: A total of 183 plastic surgery cases were evaluated across 17 primary surgeons. On average, the instrument usage per tray was 15.8% for the general plastics tray and 23.5% for the breast reconstruction tray. After stakeholder review, 32 (45.1%) of 71 instruments were removed from the general plastics tray and 40 (36.7%) of 109 were removed from the breast reconstruction tray, resulting in a total reduction of 2652 instruments. This resulted in a decrease of 81,696 instrument sterilization cycles annually. The removal of the instruments yielded an estimated cost avoidance of US $163,800 for instrument repurchase and US $69,441 in annual resterilization savings. The instrument volume reduction is projected to save 383.5 hours of sterile processing personnel time in tray assembly annually. CONCLUSIONS: An analytics-driven method applying empirical data on actual case-based instrument usage has implications for better efficiency, improved quality, and cost avoidance related to instrument repurchase and sterile processing. Given increasing cost constraints and the transition to value-based care models, leveraging a technology-based solution enables meaningful change in the sterile processing department as a source for cost reduction and quality of care improvement.

Data analysis of vascular surgery instrument trays yielded large cost and efficiency savings.

BACKGROUND: Surgical procedures account for 50% of hospital revenue and ∼60% of operating costs. On average, <20% of surgical instruments will be used during a case, and the expense for resterilization and assembly of instrument trays ranges from $0.51 to $3.01 per instrument. Given the complexity of the surgical service supply chain, physician preferences, and variation of procedures, a reduction of surgical cost has been extremely difficult and often ill-defined. A data-driven approach to instrument tray optimization has implications for efficiency and cost savings in sterile processing, including reductions in tray assembly time and instrument repurchase, repair, and avoidable depreciation. METHODS: During a 3-month period, vascular surgery cases were monitored using a cloud-based technology product (OpFlow, Operative Flow Technologies, Raleigh, NC) as a part of a hospital-wide project. Given the diversity of the cases evaluated, we focused on two main vascular surgery trays: vascular and aortic. An assessment was performed to evaluate the exact instruments used by the operating surgeons across a variety of cases. The vascular tray contained 131 instruments and was used for the vast majority of vascular cases, and the aortic tray contained 152 instruments. Actual instrument usage data were collected, a review and analysis performed, and the trays optimized. RESULTS: During the 3-month period, 168 vascular surgery cases were evaluated across six surgeons. On average, the instrument usage per tray was 30 of 131 instruments (22.9%) for the vascular tray and 19 of 152 (12.5%) for the aortic tray. After review, 45.8% of the instruments were removed from the vascular tray and 62.5% from the aortic tray, for 1255 instruments removed from the versions of both trays. An audit was performed after the removal of instruments, which showed that none of the removed instruments had required reinstatement. The instrument reduction from these two trays alone yielded an estimated costs savings of $97,781 for repurchase and $97,444 in annual resterilization savings. Annually, the removal of the instruments is projected to save 316.2 hours of personnel time. The time required for operating room table setup decreased from a mean of 7:44 to 5:02 minutes for the vascular tray (P < .0001) and from 8:53 to 4:56 minutes for the aortic tray (P < .0001). CONCLUSIONS: Given increasing cost constraints in healthcare, sterile processing remains an untapped resource for surgical expense reduction. A comprehensive data analytics solution provided the ability to make informed decisions in tray management that otherwise could not be reliably performed.

Optimal donation of kidney transplants after controlled circulatory death.

Controlled donation after circulatory death (cDCD) is used for "extended criteria" donors with poorer kidney transplant outcomes. The French cDCD program started in 2015 and is characterized by normothermic regional perfusion, hypothermic machine perfusion, and short cold ischemia time. We compared the outcomes of kidney transplantation from cDCD and brain-dead (DBD) donors, matching cDCD and DBD kidney transplants by propensity scoring for donor and recipient characteristics. The matching process retained 442 of 499 cDCD and 809 of 6185 DBD transplantations. The DGF rate was 20% in cDCD recipients compared with 28% in DBD recipients (adjusted relative risk [aRR], 1.43; 95% confidence interval [CI] 1.12-1.82). When DBD transplants were ranked by cold ischemia time and machine perfusion use and compared with cDCD transplants, the aRR of DGF was higher for DBD transplants without machine perfusion, regardless of the cold ischemia time (aRR with cold ischemia time <18 h, 1.57; 95% CI 1.20-2.03, vs aRR with cold ischemia time ≥18 h, 1.79; 95% CI 1.31-2.44). The 1-year graft survival rate was similar in both groups. Early outcome was better for kidney transplants from cDCD than from matched DBD transplants with this French protocol.

Heart Transplantation After Ventricular Assist Device Therapy: Benefits, Risks, and Outcomes.

Heart transplantation is an established treatment for end-stage heart failure. Due to the increase in demand and persistent scarcity of organ, mechanical circulatory devices have played a major role in therapy for advanced heart failure. Usage of left ventricular assist device (LVAD) has gone up from 6% in 2006 to 43% in 2013 as per the United Network of Organ Sharing database. Majority of patients presenting for a heart transplantation are often bridged with an assist device prior for management of heart failure while on wait-list. On one hand, it is well established that LVADs improve survival on wait-list; on the other hand, the effect of LVAD on morbidity and survival after a heart transplantation is still unclear. In this article, we review the available literature and attempt to infer the outcomes given the risks and benefits of heart transplantation with prior LVAD patients.