Predictive Factors for Successful Decannulation in Patients with Tracheostomies and Brain Injuries: A Systematic Review.

Neurological patients frequently have disorders of consciousness, swallowing disorders, or neurological states that are incompatible with extubation. Therefore, they frequently require tracheostomies during their stay in an intensive care unit. After the acute phase, tracheostomy weaning and decannulation are generally expected to promote rehabilitation. However, few reliable predictive factors (PFs) for decannulation have been identified in this patient population. We sought to identify PFs that may be used during tracheostomy weaning and decannulation in patients with brain injuries. We conducted a systematic review of the literature regarding potential PFs for decannulation; searches were performed on 16 March 2021 and 1 June 2022. The following databases were searched: MEDLINE, EMBASE, CINAHL, Scopus, Web of Science, PEDro, OPENGREY, OPENSIGLE, Science Direct, CLINICAL TRIALS and CENTRAL. We searched for all article types, except systematic reviews, meta-analyses, abstracts, and position articles. Retrieved articles were published in English or French, with no date restriction. In total, 1433 articles were identified; 26 of these were eligible for inclusion in the review. PFs for successful decannulation in patients with acquired brain injuries (ABIs) included high neurological status, traumatic brain injuries rather than stroke or anoxic brain lesions, younger age, effective swallowing, an effective cough, and the absence of pulmonary infections. Secondary PFs included early tracheostomy, supratentorial lesions, the absence of critical illness polyneuropathy/myopathy, and the absence of tracheal lesions. To our knowledge, this is the first systematic review to identify PFs for decannulation in patients with ABIs. These PFs may be used by clinicians during tracheostomy weaning.

A Pluridisciplinary Tracheostomy Weaning Protocol for Brain-Injured Patients, Outside of the Intensive Care Unit and Without Instrumental Assessment: Results of Pilot Study.

Concurrently to the recent development of percutaneous tracheostomy techniques in the intensive care unit (ICU), the amount of tracheostomized brain-injured patients has increased. Despites its advantages, tracheostomy may represent an obstacle to their orientation towards conventional hospitalization or rehabilitation services. To date, there is no recommendation for tracheostomy weaning outside of the ICU. We created a pluridisciplinary tracheostomy weaning protocol relying on standardized criteria but adapted to each patient's characteristics and that does not require instrumental assessment. It was tested in a prospective, single-centre, non-randomized cohort study. Inclusion criteria were age > 18 years, hospitalized for an acquired brain injury (ABI), tracheostomized during an ICU stay, and weaned from mechanical ventilation. The exclusion criterion was severe malnutrition. Decannulation failure was defined as recannulation within 96 h after decannulation. Thirty tracheostomized ABI patients from our neurosurgery department were successively and exhaustively included after ICU discharge. Twenty-six patients were decannulated (decannulation rate, 90%). None of them were recannulated (success rate, 100%). Two patients never reached the decannulation stage. Two patients died during the procedure. Mean tracheostomy weaning duration (inclusion to decannulation) was 7.6 (standard deviation [SD]: 4.6) days and mean total tracheostomy time (insertion to decannulation) was 42.5 (SD: 24.8) days. Our results demonstrate that our protocol might be able to determine without instrumental assessment which patient can be successfully decannulated. Therefore, it may be used safely outside ICU or a specialized unit. Moreover, our tracheostomy weaning duration is very short as compared to the current literature.

Usefulness of thalamic beta activity for closed-loop therapy in essential tremor.

A partial loss of effectiveness of deep brain stimulation of the ventral intermediate nucleus of the thalamus (VIM) has been reported in some patients with essential tremor (ET), possibly due to habituation to permanent stimulation. This study focused on the evolution of VIM local-field potentials (LFPs) data over time to assess the long-term feasibility of closed-loop therapy based on thalamic activity. We performed recordings of thalamic LFPs in 10 patients with severe ET using the ACTIVA™ PC + S (Medtronic plc.) allowing both recordings and stimulation in the same region. Particular attention was paid to describing the evolution of LFPs over time from 3 to 24 months after surgery when the stimulation was Off. We demonstrated a significant decrease in high-beta LFPs amplitude during movements inducing tremor in comparison to the rest condition 3 months after surgery (1.91 ± 0.89 at rest vs. 1.27 ± 1.37 µV2/Hz during posture/action for N = 8/10 patients; p = 0.010), 12 months after surgery (2.92 ± 1.75 at rest vs. 2.12 ± 1.78 µV2/Hz during posture/action for N = 7/10 patients; p = 0.014) and 24 months after surgery (2.32 ± 0.35 at rest vs 0.75 ± 0.78 µV2/Hz during posture/action for 4/6 patients; p = 0.017). Among the patients who exhibited a significant decrease of high-beta LFP amplitude when stimulation was Off, this phenomenon was observed at least twice during the follow-up. Although the extent of this decrease in high-beta LFPs amplitude during movements inducing tremor may vary over time, this thalamic biomarker of movement could potentially be usable for closed-loop therapy in the long term.

Prediction of Clinical Deep Brain Stimulation Target for Essential Tremor From 1.5 Tesla MRI Anatomical Landmarks.

Background: Deep brain stimulation is an efficacious treatment for refractory essential tremor, though targeting the intra-thalamic nuclei remains challenging. Objectives: We sought to develop an inverse approach to retrieve the position of the leads in a cohort of patients operated on with optimal clinical outcomes from anatomical landmarks identifiable by 1.5 Tesla magnetic resonance imaging. Methods: The learning database included clinical outcomes and post-operative imaging from which the coordinates of the active contacts and those of anatomical landmarks were extracted. We used machine learning regression methods to build three different prediction models. External validation was performed according to a leave-one-out cross-validation. Results: Fifteen patients (29 leads) were included, with a median tremor improvement of 72% on the Fahn-Tolosa-Marin scale. Kernel ridge regression, deep neural networks, and support vector regression (SVR) were used. SVR gave the best results with a mean error of 1.33 ± 1.64 mm between the predicted target and the active contact position. Conclusion: We report an original method for the targeting in deep brain stimulation for essential tremor based on patients' radio-anatomical features. This approach will be tested in a prospective clinical trial.

A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease.

OBJECTIVE: Asleep deep brain stimulation (DBS) for Parkinson's disease (PD) is being performed more frequently; however, motor outcomes and safety of asleep DBS have never been assessed in a prospective randomized trial. METHODS: We conducted a prospective, randomized, noncomparative trial to assess the motor outcomes of asleep DBS. Leads were implanted in the subthalamic nucleus (STN) according to probabilistic stereotactic coordinates with a surgical robot under O-arm© imaging guidance under either general anesthesia without microelectrode recordings (MER) (20 patients, asleep group) or local anesthesia with MER and clinical testing (9 patients, awake group). RESULTS: The mean motor improvement rates on the Unified Parkinson's Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication were 52.3% (95% CI: 45.4-59.2%) in the asleep group and 47.0% (95% CI: 23.8-70.2%) in the awake group, 6 months after surgery. Except for a subcutaneous hematoma, we did not observe any complications related to the surgery. Three patients (33%) in the awake group and 8 in the asleep group (40%) had at least one side effect potentially linked with neurostimulation. CONCLUSIONS: Owing to its randomized design, our study supports the hypothesis that motor outcomes after asleep STN-DBS in PD may be noninferior to the standard awake procedure.

Localization of Deep Brain Stimulation Electrode by Image Registration Is Software Dependent: A Comparative Study between Four Widely Used Software Programs.

BACKGROUND: The control of the anatomic position of the active contacts is essential to understand the effects and adapt the settings of the neurostimulation. The localization is commonly assessed by a registration between the preoperative MRI and the postoperative CT scan. However, its accuracy depends on the quality of the registration algorithm and many software programs are available. OBJECTIVE: To compare the localization of implanted deep brain stimulation (DBS) leads in the subthalamic nucleus (STN) between four registration devices. METHODS: The preoperative stereotactic MRI was co-registered and fused with the 3-month postoperative CT scan in 27 patients implanted in the STN for Parkinson's disease (53 leads). Localizations of the active contacts were calculated in the stereotactic frame space and compared between software programs. RESULTS: The coordinates of the active contacts were different between software programs in the 3 axes (p < 0.001) with a mean vectorial error between the deepest contact locations of 1.17 mm (95% CI 1.09-1.25). CONCLUSION: We found a small but significant difference in the coordinates calculated on four different devices. These results have to be considered when performing studies comparing active contact locations or when following patients with an implanted DBS lead.

[Principles of health economic evaluation for use by caregivers]. / Principes de l'évaluation médico-économique à l'usage des soignants.

The aim of health economic evaluation is to maximize health gains from limited resources. By definition, health economic evaluation is comparative, based on average costs and outcomes of compared interventions. Incremental costs and outcomes are used to calculate the cost-effectiveness ratio, which represents the average incremental cost per gained unit of effectiveness (i.e.: a year of life) with the evaluated intervention compared to the reference. The health economic rationale applies to all health domains. We cannot spend collective resources (health insurance) without asking ourselves about their potential alternative uses. This reasoning is useful to caregivers for understanding resources allocation decisions and healthcare recommandations. Caregivers should grab this field of expertise because they are central in this strategic reflection for defining the future French healthcare landscape.

Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up.

BACKGROUND: Chronic severe tinnitus can be greatly detrimental to quality of life. Some authors have reported benefit of repetitive transcranial magnetic stimulation, others of electrical cortical stimulation by stimulating the Heschl's gyrus or secondary auditory areas. OBJECTIVE: To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus. METHOD: In this double-blind randomized cross-over, patients with chronic (at least 2 years), severe (Strukturierte Tinnitus-Interview, STI score > 19), unilateral or strongly lateralized tinnitus were included. After open-phase stimulation for 4 months, patients were randomized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between. Each of the 3 phases was 2 weeks in duration. Patients were chronically stimulated and followed if not explanted. A decrease of STI score >35% was considered as clinically significant. RESULTS: None of the 9 patients included achieved significant improvement during the double-blind phase. Four were explanted, 2 owing to lack of effect, one for breast cancer under the stimulator, and another for psychiatric decompensation. Five are still stimulated. Three felt slight to great subjective effectiveness, the remaining 2 reported benefits and still requested stimulation. CONCLUSIONS: This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus. The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery, but may also be explained by a poorly defined target, a too short randomized phase, or inappropriate outcome measures. Clinical trial reference: NCT00486577.

High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial.

PURPOSE: Septic shock is a leading cause of death among critically ill patients, in particular when complicated by acute kidney injury (AKI). Small experimental and human clinical studies have suggested that high-volume haemofiltration (HVHF) may improve haemodynamic profile and mortality. We sought to determine the impact of HVHF on 28-day mortality in critically ill patients with septic shock and AKI. METHODS: This was a prospective, randomized, open, multicentre clinical trial conducted at 18 intensive care units in France, Belgium and the Netherlands. A total of 140 critically ill patients with septic shock and AKI for less than 24 h were enrolled from October 2005 through March 2010. Patients were randomized to either HVHF at 70 mL/kg/h or standard-volume haemofiltration (SVHF) at 35 mL/kg/h, for a 96-h period. RESULTS: Primary endpoint was 28-day mortality. The trial was stopped prematurely after enrolment of 140 patients because of slow patient accrual and resources no longer being available. A total of 137 patients were analysed (two withdrew consent, one was excluded); 66 patients in the HVHF group and 71 in the SVHF group. Mortality at 28 days was lower than expected but not different between groups (HVHF 37.9 % vs. SVHF 40.8 %, log-rank test p = 0.94). There were no statistically significant differences in any of the secondary endpoints between treatment groups. CONCLUSIONS: In the IVOIRE trial, there was no evidence that HVHF at 70 mL/kg/h, when compared with contemporary SVHF at 35 mL/kg/h, leads to a reduction of 28-day mortality or contributes to early improvements in haemodynamic profile or organ function. HVHF, as applied in this trial, cannot be recommended for treatment of septic shock complicated by AKI.

Effects of nefopam on early postoperative hyperalgesia after cardiac surgery.

OBJECTIVE: The purpose of this randomized, double-blind placebo-controlled study was to evaluate the effect of nefopam, a centrally acting antinociceptive compound, on the development of hyperalgesia after sternotomy. Preventive strategy giving nefopam from the early stage of anesthesia was compared with a postoperative strategy only and placebo. DESIGN: This study was double-blinded and randomized. SETTING: It was conducted in a single university hospital. PARTICIPANTS: Ninety American Society of Anesthesiologists II to III patients scheduled for elective cardiac surgery. INTERVENTIONS: Patients were assigned randomly to receive a 0.3-mg/kg bolus of nefopam at the induction of anesthesia followed by a continuous infusion of 0.065 mg/kg/h for 48 hours (G1), a 0.3-mg/kg bolus of nefopam at the end of surgery followed by a continuous infusion of 0.065 mg/kg/h for 48 hours (G2), or a placebo (G3). Postoperative analgesia was based on morphine patient-controlled analgesia and rescue analgesia when necessary. Postoperative hyperalgesia, pain scores, morphine consumption, and postoperative cognitive dysfunction were assessed for the first 48 hours and thereafter on postoperative days 4 and 7. MEASUREMENTS AND MAIN RESULTS: The postoperative extent of dynamic hyperalgesia and the decrease of the nociceptive threshold evaluated by von Frey filaments at the sternal midline were smaller in group 1 and group 2 compared with the placebo group at the 24th hour. The primary objective was the extent of hyperalgesia at the midline given as the mean (standard deviation [SD]) (4.4 [2.5] cm for G1, 4.1 [2.7] for G2, and 6.1 [2.7] cm for G3. The punctuate is given as mean (SD) (64 [43] g for G1, 68 [40.8] g for G2, and 32 [27] g for G3; with p < 0.05 for the comparisons of extent and punctuate hyperalgesia between G1 and G3 and G2 and G3). The extent of hyperalgesia was not significantly different among the 3 groups on days 2, 4, and 7 after surgery. There were no significant differences in pain scores, morphine consumption, or postoperative cognitive dysfunctions. CONCLUSIONS: Nefopam administered during the perioperative period slightly reduced acute hyperalgesia after cardiac surgery, but this was not associated with improved analgesic efficacy.

Prospective randomized study of early pulmonary evaluation of patients scheduled for aortic valve surgery performed by ministernotomy or total median sternotomy.

OBJECTIVE: The purpose of this study was to compare the respiratory function of patients operated either with a ministernotomy or with a conventional sternotomy for an aortic valve replacement. DESIGN: A prospective randomized study. SETTING: A single-institution university hospital. PARTICIPANTS: Seventy-eight patients scheduled for aortic valve replacement. INTERVENTIONS: Patients were assigned to have minimal sternotomy access (ministernotomy) or conventional median total sternotomy. Pulmonary function was measured using a mobile respiratory spirometric device preoperatively and after 1 (POD1), 2 (POD2), and 7 days (POD7) postoperatively. MEASUREMENTS AND MAIN RESULTS: There was no significant difference in any respiratory parameter measured between the 2 groups of patients. Almost all respiratory volumes decreased significantly with the same intensity in the 2 groups on POD1 (p <0.05), by about 50% from baseline. Only functional residual capacity was unchanged from baseline in the postoperative period, except for a small but significant reduction of this parameter to 60.3% +/- 27.4% in the standard sternotomy group on POD1 and 60.9% +/- 27.1% and 58.8% +/- 30.4%, respectively, in the ministernotomy and the standard group at POD7. The only significant difference concerned the intraoperative blood loss measured at 450 +/- 280 mL and 720 +/- 450 mL, respectively, in the ministernotomy and the standard group (p < 0.05), but this was not significantly associated with a reduction of total blood use. CONCLUSION: This study failed to show any improvement of respiratory function by a smaller chest incision. However, it showed a significant reduction in intraoperative bleeding but without a reduction in transfusion. Further investigations are required to assess whether this procedure could improve the outcome of cardiac surgery patients with a greater predicted risk score or pulmonary diseases.