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Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1).

ABSTRACT: Prolonged mechanical ventilation promotes diaphragmatic atrophy and weaning difficulty. The study uses a novel device containing a transvenous phrenic nerve stimulating catheter (Lungpacer IntraVenous Electrode Catheter) to stimulate the diaphragm in ventilated patients. We set out to determine the feasibility of temporary transvenous diaphragmatic neurostimulation using this device. Design:Multicenter, prospective open-label single group feasibility study. Setting:ICUs of tertiary care hospitals. Patients:Adults on mechanical ventilation for greater than or equal to 7 days that had failed two weaning trials. Interventions:Stimulation catheter insertion and transvenous diaphragmatic neurostimulation therapy up to tid, along with standard of care. Measurements and Main Results:Primary outcomes were successful insertion and removal of the catheter and safe application of transvenous diaphragmatic neurostimulation. Change in maximal inspiratory pressure and rapid shallow breathing index were also evaluated. Eleven patients met all entry criteria with a mean mechanical ventilation duration of 19.7 days; nine underwent successful catheter insertion. All nine had successful mapping of one or both phrenic nerves, demonstrated diaphragmatic contractions during therapy, and underwent successful catheter removal. Seven of nine met successful weaning criteria. Mean maximal inspiratory pressure increased by 105% in those successfully weaned (mean change 19.7 ± 17.9?cm H2O; p = 0.03), while mean rapid shallow breathing index improved by 44% (mean change -63.5 ± 64.4; p = 0.04). Conclusions:The transvenous diaphragmatic neurostimulation system is a feasible and safe therapy to stimulate the phrenic nerves and induce diaphragmatic contractions. Randomized clinical trials are underway to compare it to standard-of-care therapy for mechanical ventilation weaning.

SUBMITTER: Ataya A

PROVIDER: S-EPMC7188416 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1).

Ataya Ali A Silverman Erin P EP Bagchi Aranya A Sarwal Aarti A Criner Gerard J GJ McDonagh David L DL

Critical care explorations 20200429 4

Prolonged mechanical ventilation promotes diaphragmatic atrophy and weaning difficulty. The study uses a novel device containing a transvenous phrenic nerve stimulating catheter (Lungpacer IntraVenous Electrode Catheter) to stimulate the diaphragm in ventilated patients. We set out to determine the feasibility of temporary transvenous diaphragmatic neurostimulation using this device.<h4>Design</h4>Multicenter, prospective open-label single group feasibility study.<h4>Setting</h4>ICUs of tertiary ...[more]

PMID: 32426748

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Project description:IntroductionOxygen is the most commonly administered drug to mechanically ventilated critically ill adults, yet little is known about the optimum oxygen saturation (SpO2) target for these patients; the current standard of care is an SpO2 of 96% or above. Small pilot studies have demonstrated that permissive hypoxaemia (aiming for a lower SpO2 than normal by using a lower fractional inspired oxygen concentration (FIO2)) can be achieved in the critically ill and appears to be safe. This approach has not been evaluated in a National Health Service setting. It is possible that permissive hypoxaemia may be beneficial to critically ill patients thus it requires robust evaluation.Methods and analysisTargeted OXygen therapY in Critical illness (TOXYC) is a feasibility randomised controlled trial (RCT) to evaluate whether recruiting patients to a study of permissive hypoxaemia is possible in the UK. It will also investigate biological mechanisms that may underlie the links between oxygenation and patient outcomes. Mechanically ventilated patients with respiratory failure will be recruited from critical care units at two sites and randomised (1:1 ratio) to an SpO2 target of either 88%-92% or ≥96% while intubated with an endotracheal tube. Clinical teams can adjust FIO2 and ventilator settings as they wish to achieve these targets. Clinical information will be collected before, during and after the intervention and blood samples taken to measure markers of systemic oxidative stress. The primary outcome of this study is feasibility, which will be assessed by recruitment rate, protocol adherence and withdrawal rates. Secondary outcomes will include a comparison of standard critical care outcome measures between the two intervention groups, and the measurement of biomarkers of systemic oxidative stress. The results will be used to calculate a sample size, likely number of sites and overall length of time required for a subsequent large multicentre RCT.Ethics and disseminationThis study was approved by the London - Harrow Research Ethics Committee on 2 November 2017 (REC Reference 17/LO/1334) and received HRA approval on 13 November 2017. Results from this study will be disseminated in peer-reviewed journals, at medical and scientific meetings, in the NIHR Journals Library and patient information websites.Trial registration numberNCT03287466; Pre-results.

Project description:ObjectiveKetamine has been shown to decrease sedative requirements in intensive care unit (ICU). Randomized trials are limited on patient-centered outcomes. We designed this pilot trial to evaluate the feasibility of a large randomized controlled trial (RCT) testing the effect of ketamine as an adjunct analgosedative compared with standard of care alone as a control group (CG) in critically ill patients with mechanical ventilation (MV). We also provided preliminary evidence on clinically relevant outcomes to plan a larger trial.Material and methodsPilot, active-controlled, open-label RCT was conducted at medical, surgical, and transplant ICUs at a large tertiary and quaternary care medical institution (King Faisal Specialist Hospital and Research Center, Saudi Arabia). The study included adult patients who were intubated within 24 h, expected to require MV for the next calendar day, and had institutional pain and sedation protocol initiated. Patients were randomized in a 1:1 ratio to adjunct ketamine infusion 1-2 μg/kg/min for 48 h or CG alone.ResultsOf 437 patients screened from September 2019 through November 2020, 83 (18.9%) patients were included (43 in CG and 40 in ketamine) and 352 (80.5%) were excluded. Average enrollment rate was 3-4 patients/month. Consent and protocol adherence rates were adequate (89.24% and 76%, respectively). Demographics were balanced between groups. Median MV duration was 7 (interquartile range [IQR] 3-9.25 days) in ketamine and 5 (IQR 2-8 days) in CG. Median VFDs was 19 (IQR 0-24.75 days) in ketamine and 19 (IQR 0-24 days) in the CG (p = 0.70). More patients attained goal Richmond Agitation-Sedation Scale at 24 and 48 h in ketamine (67.5% and 73.5%, respectively) compared with CG (52.4% and 66.7%, respectively). Sedatives and vasopressors cumulative use, and hemodynamic changes were similar. ICU length-of-stay was 12.5 (IQR 6-21.2 days) in ketamine, compared with 12 (IQR 5.5-23 days) in CG. No serious adverse events were observed in either group.ConclusionsKetamine as an adjunct analgosedative agent appeared to be feasible and safe with no negative impact on outcomes, including hemodynamics. This pilot RCT identified areas of improvement in study protocol before conducting a large, adequately powered, multicenter RCT which is likely justified to investigate ketamine association with patient-centered outcomes further. Trial registration ClinicalTrials.gov: NCT04075006. Registered on 30 August 2019. Current controlled trials: ISRCTN14730035. Registered on 3 February 2020.

Project description:ObjectivesDeep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial.DesignPragmatic, multicenter ( n = 3), prospective before-after pilot and feasibility trial.SettingThe ED and ICUs at three medical centers.PatientsConsecutive, adult mechanically ventilation ED patients.InterventionsAn educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome).Measurements and main resultsSedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of -3 to -5 or a Sedation-Agitation Scale of 1-3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% ( p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group ( p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both.ConclusionsThis pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.

Project description:BackgroundSeveral studies have assessed predictors of weaning and extubation outcome in short-term mechanically ventilated patients, but there are only few studies on predictors of weaning from prolonged mechanical ventilation.MethodsRetrospective, single-center, observational study at a specialized national weaning center in Germany. Patients' medical records were reviewed to obtain data on demographics, comorbidities, respiratory indices, and the result of a prospectively documented, standardized spontaneous breathing trial (SBT) upon admission to the weaning center. Respiratory indices assessed were the ventilatory ratio (VR) and parameters derived from calculated mechanical power (MP). Predictors associated with failure of prolonged weaning and failure of the SBT were assessed using a binary logistic regression model.ResultsA total of 263 prolonged mechanically ventilated, tracheotomized patients, treated over a 5-year period were analyzed. After 3 weeks of mechanical ventilation, patients with unsuccessful weaning failed a SBT more frequently and showed significantly increased values for inspiratory positive airway pressure, driving pressure, VR, absolute MP, and MP normalized to predicted body weight and dynamic lung-thorax compliance (LTC-MP). In the logistic regression analyses, variables independently correlated with weaning failure were female gender (adjusted odds ratio 0.532 [95% CI 0.291-0.973]; p = 0.040), obesity (body mass index ≥ 30 kg/m2) (2.595 [1.210-5.562]; p = 0.014), COPD (3.209 [1.563-6.589]; p = 0.002), LTC-MP (3.470 [1.067-11.284]; p = 0.039), PaCO2 on mechanical ventilation (1.101 [95% CI 1.034-1.173]; p = 0.003), and failure of the SBT (4.702 [2.250-9.825]; p < 0.001). In addition, female gender (0.401 [0.216-0.745]; p = 0.004), LTC-MP (3.017 [1.027-8.862]; p = 0.046), and PaCO2 on mechanical ventilation (1.157 [1.083-1.235]; p < 0.001) were independent risk factors for an unsuccessful SBT.ConclusionsIn the present study, the derived predictors of weaning point to a crucial role of the workload imposed on respiratory muscles during spontaneous breathing. Mechanical power normalized to lung-thorax compliance was independently correlated with weaning outcome and may identify patients at high risk for weaning failure.

Project description:Sonographic assessment of diaphragmatic thickness and excursion has been found to be an accurate tool in predicting successful extubation of adult patients from invasive mechanical ventilation. We aimed to evaluate the accuracy of sonographic assessment of diaphragmatic thickness and excursion in predicting successful extubation of preterm infants from invasive conventional mechanical ventilation. Preterm infants less than 32 weeks gestation who required invasive conventional mechanical ventilation were evaluated by diaphragmatic sonography within 1 h of their planned extubation. Infants were classified into successful or failed extubation groups based on their ability to stay off invasive mechanical ventilation for 72 h after extubation. Inspiratory and expiratory thickness plus excursion of the right and left hemidiaphragm as well as diaphragmatic thickening fraction (DTF) measures were compared between groups. We included 43 eligible infants, of whom 34 infants succeeded and 9 infants failed extubation. Infants in the successful extubation group had a significantly higher expiratory thickness of the right and left hemidiaphragm, excursion of the right and left hemidiaphragm, inspiratory thickness of the left hemidiaphragm, and DTF of the left hemidiaphragm compared with infants who failed extubation. The receiver-operating characteristic curves showed that excursion of the right and left hemidiaphragm has the highest significant accuracy in predicting successful extubation of preterm infants among all diaphragmatic parameters (AUC is 0.98 and 0.96, respectively; p value < 0.001 for both).Conclusion: We conclude that diaphragmatic excursion is a useful indicator for successful extubation of preterm infants from mechanical ventilation. What is Known: • Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction (VIDD) particularly when used for long time. • Assessment of diaphragmatic dimensions and functional activity has been a valuable tool in predicting successful extubation of adult patients from invasive mechanical ventilation. What is New: • Sonographic assessment of diaphragmatic dimensions can be used to predict successful extubation of preterm infants from mechanical ventilation. • Sonographic assessment of diaphragmatic excursion shows the highest sensitivity and specificity in predicting successful extubation of preterm infants.

Dataset Information

Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1).

Publications

Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1).

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