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Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

ABSTRACT: 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.

SUBMITTER: Evans D

PROVIDER: S-EPMC6337771 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

Evans Douglas D Shure Deborah D Clark Linda L Criner Gerard J GJ Dres Martin M de Abreu Marcelo Gama MG Laghi Franco F McDonagh David D Petrof Basil B Nelson Teresa T Similowski Thomas T

Trials 20190117 1

<h4>Background</h4>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.<h4>Methods and analysis</h4>This paper describes the protocol of a randomized, controlled, op ...[more]

PMID: 30654837

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Project description:BACKGROUND Prolonged mechanical ventilation (PMV) after cardiac surgery occurs in 12% of patients, and significantly increases morbidity and mortality. Diaphragm pacing (DP) decreases ventilation times by 64% in other patient groups. We investigated the feasibility and outcomes of DP in urgent cardiac surgeries to decrease ventilator burden during the COVID-19 pandemic. METHODS AND RESULTS This pilot study is an open-label FDA (IDE# G170294) prospective trial of temporary DP electrode use in high risk cardiac surgery patients (ClinicalTrials.gov Identifier–NCT04309123). Prior to sternotomy closure, the pleural space is opened, two electrodes (Figure 1) are placed in each diaphragm muscle, and the wires are tunneled percutaneously. The electrodes record diaphragm burst electromyography (dEMG) continuously for the first 24 hours and then once daily (Figure 2). In PMV patients (MV>24 hours), DP is initiated to prevent diaphragm atrophy and ventilator induced diaphragm dysfunction. The primary outcome was incidence of serious device related adverse events. The secondary outcome was time on MV. From 4/2/20–6/25/20, 44 patients were consented, 32 were implanted, and 12 were not. PMV was required in 10 patients implanted and 4 not implanted. There were no serious adverse events related to DP electrode implantation, all stimulated patients had improved ventilation and diaphragm function, and all electrodes were removed successfully. Criteria that best predicted PMV were: IABP, history of TIA or CVA, COPD, LVEF < 20%, and prior open-heart surgery. Using these criteria, the median time on mechanical ventilation in the first 120 hours was 35.7% versus 80.0% for the stimulated and non-stimulated groups, respectively. CONCLUSION Temporary DP electrode placement during cardiac surgery is feasible and safe. DP improved diaphragm function and ventilation, and increased the likelihood of extubation by 48 hours. These results provide a catalyst for a prospective randomized controlled trial to decrease the MV burden in an enhanced recovery after surgery (ERAS) protocol.

Project description:BackgroundDiaphragmatic pacing can improve diaphragm function, which is beneficial for the prognosis of patients treated with prolonged mechanical ventilation (MV). While most previous studies have focused on the role of implanted diaphragm pacing (IDP), our study is the first to examine the effects of external diaphragmatic pacing (EDP) in mechanically ventilated patients. Specifically, the effect of EDP on diaphragm function, the success rate of weaning, the duration of MV (DMV), and the intensive care unit (ICU) length of stay (ILOS) were assessed.MethodsFrom September 2019 to December 2020, a total of 51 mechanically ventilated patients in the ICU of the Sun Yat-sen Memorial Hospital, Sun Yat-sen University were enrolled and randomly divided into an EDP group of 27 patients and a control group of 24 patients. The control group received routine treatment, and the EDP group received EDP treatment in addition to routine treatment. The diaphragm excursion (DE), diaphragm thickening fraction (DTF), DMV, ILOS, and average survival time were recorded to evaluate efficacy.ResultsPatients treated with EDP had increased DE [exp(B) =1.86, 95% CI: 1.39 to 2.50, P<0.001] and DTF [exp(B) =1.35, 95% CI: 1.05 to 1.76, P=0.022], shortened weaning time (P=0.026) and prolonged average survival time (P<0.001) compared to patients who did not receive EDP therapy. Especially in cases with difficult weaning, the improvement of DE and DTF in the EDP treatment group was more obvious than that in the control group (P=0.013 and P=0.032). Moreover, the DTF upon attempted spontaneous breathing trial (SBT) was negatively correlated with the fraction of inspired oxygen (FiO2) [r=-0.54; 95% confidence interval (CI): -0.77 to -0.19; P=0.004], the arterial partial pressure of oxygen (PaO2) (r=-0.58; 95% CI: -0.79 to -0.25; P=0.001), the PaO2/FiO2 ratio (r=-0.52; 95% CI: -0.75 to -0.16; P=0.006), and the serum lactate concentration (Lac) (r=-0.39; 95% CI: -0.68 to 0.003; P=0.046).ConclusionsEDP treatment can effectively reduce the DMV and prolong the average survival time of mechanically ventilated patients.Trial registrationChinese Clinical Trial Registry ChiCTR1900024096.

Project description:BackgroundLung and diaphragm ultrasound methods have recently been introduced to predict the outcome of weaning from mechanical ventilation (MV). The aim of this study is to assess the reliability and accuracy of these techniques for predicting successful weaning in critically ill adults.MethodsWe conducted two studies: a cross-sectional interobserver agreement study between two sonographers and a prospective cohort study to assess the accuracy of lung and diaphragm ultrasound for predicting weaning and extubation outcome. For the interobserver agreement study, we included 50 general critical care patients who were consecutively admitted to the ICU. For the predictive accuracy study, we included consecutively 69 patients on MV who were ready for weaning. We assessed interobserver agreement of ultrasound measurements, using the weighted kappa coefficient for LUSm score (modified lung ultrasound score) and the intraclass correlation coefficient (ICC) and Bland-Altman method for TI (diaphragm thickening index). We assessed the predictive value of LUSm and TI in weaning outcome by plotting the corresponding ROC curves.ResultsWe found adequate interobserver agreement for both LUSm (weighted kappa 0.95) and TI (ICC 0.78, difference according to Bland-Altman analysis?±?12.5%). LUSm showed good-moderate discriminative power for successful weaning and extubation (area under the ROC curve (AUC) for successful weaning 0.80, and sensitivity and specificity at optimal cut-off point 0.76 and 0.73, respectively; AUC for successful extubation 0.78, and optimal sensitivity and specificity 0.76 and 0.47, respectively. TI was more sensitive but less specific for predicting successful weaning (AUC 0.71, optimal sensitivity and specificity 0.93 and 0.48) and successful extubation (AUC 0.76, optimal sensitivity and specificity 0.93 and 0.58). The area under the ROC curve for predicting weaning success was 0.83 for both ultrasound measurements together.ConclusionsInterobserver agreement was excellent for LUSm and moderate-good for TI. A low TI value or high LUSm value indicates high risk of weaning failure.

Project description:IntroductionNeuromuscular diseases (NMD) are characterised by progressive muscular impairment. The muscle weakness is directly related to respiratory muscles weakness, causing reduction in vital capacity, especially when associated with mechanical ventilation (MV). Conventional MV weaning in NMD is generally difficult. Weaning process can be conducted in protocols such as: 'T' piece or Pressure Support Ventilaton. Weaning failure is frequent because of muscle weakness. Protocol aim is to assess the effects of different weaning protocols in NMD patients receiving invasive MV in weaning success rate, duration of weaning, intensive care unit (ICU) stay, hospital stay and ICU mortality.Methods and analysisA search will be carried in the Cochrane Neuromuscular Specialised Register, MEDLINE, EMBASE, Web of Science, Scopus, United States National Institutes of Health Clinical Trials Registry, ClinicalTrials.gov and WHO International Clinical Trial Registry Protal, of randomised controlled trials (RCTs) and quasi-RCTs. Inclusion criteria of individuals are adults (above 16 years old) and children (from 5 to 16 years old), with clinical diagnosis of NMD (muscular dystrophy, amyotrophic lateral sclerosis, congenital myasthenia, myasthenia gravis, congenital myopathy, spinal muscular atrophy, Guillian Barré Syndrome, severe inherited neuropathies, metabolic myopathies, inflammatory myopathies, mitochondrial diseases) of any gender. All patients ventilated for at least 48 hours due to respiratory failure and clinically considered ready for weaning. Other respiratory or cardiovascular diagnosis associated will not be included. Intervention assessed will be weaning from MV using a protocol with 30 min to 2 hours of spontaneous breathing trial at the end point. All comparisons of different protocols will be considered.Ethics and disseminationFormal ethical approval is not required as primary data will not be collected, since it will be a systematic review. All studies included should have ethical committee approval. The results will be disseminated through a peer-reviewed publication and in conferences and congresses or symposia.Prospero registration numberCRD42019117393.

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Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

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Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.

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