Explore the vast range of titles available.

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder associated with respiratory muscle weakness and respiratory failure. Non-invasive ventilation alleviates respiratory symptoms and prolongs life, but is a palliative intervention. Slowing the deterioration of diaphragm function before respiratory failure would be desirable. We aimed to assess whether early diaphragm pacing could slow down diaphragm deterioration and would therefore delay the need for non-invasive ventilation. We did a multicentre, randomised, controlled, triple-blind trial in patients with probable or definite ALS in 12 ALS centres in France. The main inclusion criterion was moderate respiratory involvement (forced vital capacity 60–80% predicted). Other key eligibility criteria were age older than 18 years and bilateral responses of the diaphragm to diagnostic phrenic stimulation. All patients were operated laparoscopically and received phrenic stimulators. Clinicians randomly assigned patients (1:1) to receive either active or sham stimulation with a central web-based randomisation system (computer-generated list). Investigators, patients, and an external outcome allocation committee were masked to treatment. The primary outcome was non-invasive ventilation-free survival, analysed in the intention-to-treat population. Safety outcomes were also assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01583088. Between Sept 27, 2012, and July 8, 2015, 74 participants were randomly assigned to receive either active (n=37) or sham (n=37) stimulation. On July 16, 2015, an unplanned masked analysis was done after another trial showed excess mortality with diaphragm pacing in patients with hypoventilation (DiPALS, ISRCTN 53817913). In view of this finding, we analysed mortality in our study and found excess mortality (death from any cause) in our active stimulation group. We therefore terminated the study on July, 16, 2015. Median non-invasive ventilation-free survival was 6·0 months (95% CI 3·6–8·7) in the active stimulation group versus 8·8 months (4·2–not reached) in the control (sham stimulation) group (hazard ratio 1·96 [95% CI 1·08–3·56], p=0·02). Serious adverse events (mainly capnothorax or pneumothorax, acute respiratory failure, venous thromboembolism, and gastrostomy) were frequent (24 [65%] patients in the active stimulation group vs 22 [59%] patients in the control group). No treatment-related death was reported. Early diaphragm pacing in patients with ALS and incipient respiratory involvement did not delay non-invasive ventilation and was associated with decreased survival. Diaphragm pacing is not indicated at the early stage of the ALS-related respiratory involvement. Hospital Program for Clinical Research, French Ministry of Health; French Patients' Association for ALS Research (Association pour la Recherche sur la Sclérose Latérale Amyotrophique); and Thierry de Latran Foundation.

Introduction The objective was to compare the impact of three assistance levels of different modes of mechanical ventilation; neurally adjusted ventilatory assist (NAVA), proportional assist ventilation (PAV), and pressure support ventilation (PSV) on major features of patient-ventilator interaction. Methods PSV, NAVA, and PAV were set to obtain a tidal volume (V T ) of 6 to 8 ml/kg (PSV 100 , NAVA 100 , and PAV 100 ) in 16 intubated patients. Assistance was further decreased by 50% (PSV 50 , NAVA 50 , and PAV 50 ) and then increased by 50% (PSV 150 , NAVA 150 , and PAV 150 ) with all modes. The three modes were randomly applied. Airway flow and pressure, electrical activity of the diaphragm (EAdi), and blood gases were measured. V T , peak EAdi, coefficient of variation of V T and EAdi, and the prevalence of the main patient-ventilator asynchronies were calculated. Results PAV and NAVA prevented the increase of V T with high levels of assistance (median 7.4 (interquartile range (IQR) 5.7 to 10.1) ml/kg and 7.4 (IQR, 5.9 to 10.5) ml/kg with PAV 150 and NAVA 150 versus 10.9 (IQR, 8.9 to 12.0) ml/kg with PSV 150 , P <0.05). EAdi was higher with PAV than with PSV at level 100 and level 150 . The coefficient of variation of V T was higher with NAVA and PAV (19 (IQR, 14 to 31)% and 21 (IQR 16 to 29)% with NAVA 100 and PAV 100 versus 13 (IQR 11 to 18)% with PSV 100 , P <0.05). The prevalence of ineffective triggering was lower with PAV and NAVA than with PSV ( P <0.05), but the prevalence of double triggering was higher with NAVA than with PAV and PSV ( P <0.05). Conclusions PAV and NAVA both prevent overdistention, improve neuromechanical coupling, restore the variability of the breathing pattern, and decrease patient-ventilator asynchrony in fairly similar ways compared with PSV. Further studies are needed to evaluate the possible clinical benefits of NAVA and PAV on clinical outcomes. Trial registration Clinicaltrials.gov NCT02056093 . Registered 18 December 2013.

Background Ventilator-induced diaphragmatic dysfunction (VIDD) occurs in up to 60% of mechanically ventilated patients and prolongs ventilatory dependance. The consequences of VIDD are muscle atrophy, reduction of strength, and injury of muscle fibers. Atrophy and contractile activity of the diaphragm can be estimated by ultrasound muscle thickness and thickening fraction. Prior experience demonstrates invasive electrical stimulation of the diaphragm helps preserve muscle thickness. This is the first study on a non-invasive phrenic nerve stimulator that aims to assess its feasibility, safety, and usefulness in preserving diaphragm thickness. Methods A multi-center randomized clinical trial will be performed in four intensive care units (ICUs) in the United States of America and Canada. Inclusion criteria include patients older than 21 years, in the first 48 h of mechanical ventilation (MV) and predicted to remain on the ventilator for at least 48 h. Patients with contraindications for phrenic nerve stimulation, severe chronic pulmonary diseases, or impossibility to measure diaphragm thickness with ultrasound will be excluded. Patients enrolled will be randomized to standard care (control) or 30-min daily non-invasive phrenic nerve stimulation up to 10 days after enrollment (intervention). The primary effectiveness endpoint is the change in diaphragm thickness on day 10, extubation, or death whichever occurs first. Secondary endpoints include change in diaphragm thickness on day 4, maximal inspiratory pressure before extubation, and time-to rapid shallow breathing index (RSBI) <105. Safety objectives include the proportion of device- or procedure-related adverse events (SAE). The estimated sample size will be 40 patients (20 per group). Discussion The STIMIT ACTIVATOR trial is a randomized multi-center study powered to elucidate whether non-invasive phrenic nerve stimulation is feasible, safe, and preserves diaphragm thickness. Meeting the primary endpoint will demonstrate its applicability in clinical practice to prevent diaphragmatic atrophy in ventilated patients. Trial registration ClinicalTrials.gov: NCT05883163, August 29, 2023.

Regional anesthesia is a popular method for surgical anesthesia in clavicular surgery. Selective blocking of the cervical 3, 4, and 5 nerve roots shows promise in clavicle surgery, with its fast onset, good anesthesia and less complications, necessitating evaluation of its impact on diaphragmatic function. The purpose of this study is to examine the safety of C3, 4, and 5 nerve root block for its application in clavicle surgery. We conducted a pragmatic, randomized trial to evaluate the effect of C3, 4, and 5 nerve root block as compared with interscalene with intermediate cervical plexus block in diaphragmatic motion. This study involved forty patients undergoing right clavicle surgery. Patients were assigned in a 1:1 ratio to either a C345 nerve root block (administered with 2, 3, and 5 ml of 0.5% ropivacaine) or an interscalene with intermediate cervical plexus block (ISB + ICPB, each receiving 10 ml of 0.5% ropivacaine). Diaphragmatic kinetics were quantitatively assessed using sonographic techniques. The primary outcome was the incidence of complete hemi-diaphragmatic paralysis, observed at 30 min post-blockade. Secondary outcomes included the rate of complete hemi-diaphragmatic paralysis at 15 min and the degree of diaphragmatic motion restoration at 2, 4, 6, and 8 h post-blockade, onset time of block, motor block score in upper extremity, and adverse events. Results showed that only one patient (5%) in the C345 group vs. fifteen (75%) in the ISB + ICPB group experienced complete hemi-diaphragmatic paralysis at 30 min during deep breathing (P = 0.001). No patients in the C345 group, compared to five (25%) in the ISB + ICPB group exhibited paradoxical movement at 30 min during voluntary sniffing (P = 0.0471). Additionally, the C345 group demonstrated significantly greater diaphragmatic motion and upper limb strength restoration at all measured intervals post-blockade. Moreover, faster onset time and less adverse events were observed in the C345 group vs. in the ISB + ICPB group. Benefit from low volume of local anesthetics, the C345 nerve root block not only significantly reduces the incidence of complete hemi-diaphragmatic paralysis but also facilitates better recovery from diaphragmatic paralysis compared to the ISB + ICPB. It can be inferred that C345 is a more beneficial anesthesia method for early recovery of clavicular patients. Trial registration number : ChiCTR2300078283 04/12/2023.

Background and objectivesDiaphragmatic paralysis following supraclavicular brachial plexus block (SCBPB) is ascribed to phrenic nerve palsy. This study investigated the effect of 2 volumes of 0.375% ropivacaine on efficacy of block as a surgical anesthetic and as an analgesic and examined diaphragm compound muscle action potentials (CMAPs) and pulmonary function before and after SCBPB.MethodsEighty patients scheduled for removal of hardware for internal fixation after healing of an upper limb fracture distal to the shoulder were randomized to receive ultrasound-guided SCBPC for surgical anesthesia with 20 mL (Group A) or 30 mL (Group B) 0.375% ropivacaine. The latency and amplitude of diaphragm CMAPs and forced vital capacity (FVC), FVC% predicted, and forced expiratory volume in 1 s (FEV1) were measured before and 30 min after SCBPB.ResultsBlock success as primary anesthetic in addition to analgesia was 81% in Group A and 91% in Group B. There were no obvious differences in the effectiveness of analgesia between the two groups. The mean time to onset of motor block was significantly longer in Group A (8.1±2.7 min) than in Group B (5.4 ± 2.8 min; p<0.05). The mean amplitude of the diaphragm CMAP was significantly lower in Group B than in Group A (p=0.03). The changes in FVC (Group A, − 8.1% vs Group B, −16.5%), FVC% (Group A, −8.0% vs Group B, −17.1%), and FEV1 (Group A, −9.5% vs Group B, −15.2%) from pre-SCBPB to post-SCBPB were significantly less in Group A than in Group B (all p=0.03).ConclusionsThe incidence rates of phrenic nerve palsy and diaphragm paralysis were reduced, and lung function was less impaired in patients who received 20 mL vs 30 mL of 0.375% ropivacaine without any differences in block success. Selecting a lower volume of anesthetic for nerve block may be especially beneficial in obese patients or patients with cardiopulmonary disease.Trial registration numberChiCTR-IND-17012166.

Objective Neurally adjusted ventilatory assist (NAVA) is a new mode wherein the assistance is provided in proportion to diaphragm electrical activity (EAdi). We assessed the physiologic response to varying levels of NAVA and pressure support ventilation (PSV). Setting ICU of a University Hospital. Patients Fourteen intubated and mechanically ventilated patients. Design and protocol Cross-over, prospective, randomized controlled trial. PSV was set to obtain a V t /kg of 6–8 ml/kg with an active inspiration. NAVA was matched with a dedicated software. The assistance was decreased and increased by 50% with both modes. The six assist levels were randomly applied. Measurements Arterial blood gases (ABGs), tidal volume ( V t /kg), peak EAdi, airway pressure (Paw), neural and flow-based timing. Asynchrony was calculated using the asynchrony index (AI). Results There was no difference in ABGs regardless of mode and assist level. The differences in breathing pattern, ventilator assistance, and respiratory drive and timing between PSV and NAVA were overall small at the two lower assist levels. At the highest assist level, however, we found greater V t /kg (9.1 ± 2.2 vs. 7.1 ± 2 ml/kg, P  < 0.001), and lower breathing frequency (12 ± 6 vs. 18 ± 8.2, P  < 0.001) and peak EAdi (8.6 ± 10.5 vs. 12.3 ± 9.0, P  < 0.002) in PSV than in NAVA; we found mismatch between neural and flow-based timing in PSV, but not in NAVA. AI exceeded 10% in five (36%) and no (0%) patients with PSV and NAVA, respectively ( P  < 0.05). Conclusions Compared to PSV, NAVA averted the risk of over-assistance, avoided patient–ventilator asynchrony, and improved patient–ventilator interaction.

Background In the United States in 2017, there were an estimated 903,745 hospitalizations involving mechanical ventilation (MV). Complications from ventilation can result in longer hospital stays, increased risk of disability, and increased healthcare costs. It has been hypothesized that electrically pacing the diaphragm by phrenic nerve stimulation during mechanical ventilation may minimize or reverse diaphragm dysfunction, resulting in faster weaning. Methods The ReInvigorate Trial is a prospective, multicenter, randomized, controlled clinical trial evaluating the safety and efficacy of Stimdia’s pdSTIM System for facilitating weaning from MV. The pdSTIM system employs percutaneously placed multipolar electrodes to stimulate the cervical phrenic nerves and activate contraction of the diaphragm bilaterally. Patients who were on mechanical ventilation for at least 96 h and who failed at least one weaning attempt were considered for enrollment in the study. The primary efficacy endpoint was the time to successful liberation from mechanical ventilation (treatment vs. control). Secondary endpoints will include the rapid shallow breathing index and other physiological and system characteristics. Safety will be summarized for both primary and additional analyses. All endpoints will be evaluated at 30 days or at the time of removal of mechanical ventilation, whichever is first. Discussion This pivotal study is being conducted under an investigational device exception with the U.S. Food and Drug Administration. The technology being studied could provide a first-of-kind therapy for difficult-to-wean patients on mechanical ventilation in an intensive care unit setting. Trial registration Clinicaltrials.gov, NCT05998018 , registered August 2023.

Objectives The incidence of hemidiaphragmatic paresis (HDP) in superior trunk block (STB) usually depends on the dose of local anesthetic. This study aimed to further evaluate the impact of a lower volume (10 mL) of the same low concentration (0.25%) ropivacaine compared to a conventional volume (15 mL), on diaphragmatic function and analgesic efficacy under a multimodal analgesia regimen for shoulder arthroscopy. Methods Patients scheduled to undergo shoulder arthroscopy were randomized allocated to receive either 10 mL or 15 mL of 0.25% ropivacaine in the STB under ultrasound guidance prior to general anesthesia. The primary outcome was the percentage reduction in diaphragm excursion (ΔDE) between baseline and 30 min after block. Secondary outcomes included DE and diaphragm thickening fraction (DTF) before and after block, incidence of HDP, onset of sensory/motor block, duration of analgesia/motor block, dermatomal coverage area of the block, postoperative pain severity, pre- and post-block respiratory function and intraoperative hemodynamic parameters, the use of other anesthetic and analgesic drugs, post-block complications, and adverse events post-surgery. Results Compared with 15 mL volume, 10 mL ropivacaine significantly reduced the incidence of post-block HDP (as measured by ΔDE: 39.47% vs. 64.10%; and by post-block DTF: 13.16% vs. 33.33%). There was no significant difference in onset of sensory block, duration of analgesia/motor block, dermatomal coverage area of the block, postoperative pain severity between the two groups, except that the onset of motor block was significantly slower in the 10 mL group than in the 15 mL group. Pre- and post-block respiratory function and intraoperative hemodynamic parameters, the use of other anesthetic and analgesic drugs, post-block complications, or postoperative adverse events were not significantly different between the two groups. Conclusion In shoulder arthroscopy, STB with 10 mL of ropivacaine can reduce the incidence of HDP with no significant difference in analgesic effects under a multimodal analgesia regimen compared with 15 mL. Trial registration : We registered the study at chictr.org ( ChiCTR2200057543 , 14/03/2022. https://www.chictr.ogr.cn

Interscalene brachial plexus block is associated with 100% incidence of hemidiaphragmatic paresis as a result of phrenic nerve block. We examined whether an ultrasound (US)-guided interscalene brachial plexus block performed at the level of root C7 versus a nerve stimulation interscalene brachial plexus block, both using 10 mL of ropivacaine 0.75%, resulted in a lower incidence of hemidiaphragmatic paresis. In a prospective randomized controlled trial, 30 patients scheduled for elective shoulder surgery under combined general anesthesia and interscalene brachial plexus block were included. Interscalene brachial plexus block using the same dose was performed using either US or nerve stimulation guidance of ropivacaine for both groups. General anesthesia was standardized. Ventilatory function was assessed using spirometry, and movement of the hemidiaphragm was assessed by US. Two patients in the US group showed complete paresis of the hemidiaphragm, but in the nerve stimulation group, 12 patients showed complete and 2 patients had partial paresis of the hemidiaphragm (13% versus 93%, respectively; P < 0.0001). Ventilatory function (forced expiratory volume at 1 second, forced vital capacity, and peak expiratory flow) was significantly reduced in the nerve stimulation group compared with the US-guided group (P < 0.05). One block failure occurred in the nerve stimulation group compared with none in the US group. No adverse effects occurred in either group. Ultrasound-guided interscalene brachial plexus block performed at the level of root C7 using 10 mL of ropivacaine 0.75% reduces the incidence of hemidiaphragmatic paresis.

Background Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality. Methods and analysis This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization. Discussion This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP. Trial registration ClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.