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

Evans, D. Gareth; Shure, Deborah; Clark, Linda A.; Criner, Gerard J.; Dres, Martin; Abreu, Marcelo Gama de; Laghi, Franco; McDonagh, David L.; Petrof, Basil J.; Nelson, Teresa; Similowski, Thomas

doi:10.1186/s13063-018-3171-9

Cited by 22 publications

(21 citation statements)

References 66 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…TTDN appears to be a feasible and safe means of diaphragm pacing in patients with difficulty weaning from MV and also demonstrates the potential for therapeutic efficacy. This will be tested in two prospective randomized efficacy trials that are currently underway (31). TTDN effectively strengthened the diaphragm, as shown by improved inspiratory muscle strength and respiratory function, in patients who required prolonged MV and who previously failed at least two weaning attempts.…”

Section: Discussionmentioning

confidence: 99%

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

Ataya

Silverman

Bagchi

et al. 2020

Critical Care Explorations

Self Cite

View full text Add to dashboard Cite

Objectives: 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.

show abstract

Section: Discussionmentioning

confidence: 99%

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

Ataya

Silverman

Bagchi

et al. 2020

Critical Care Explorations

Self Cite

View full text Add to dashboard Cite

show abstract

“…OEIS contracted to develop and maintain the registry data entry system and database using this customizable and fully secure system. 36 Registry users can log into the EDS through a secure web page using any device or computer with web access. Once the procedural data are submitted, the Registry receives de-identified data for analysis.…”

Section: Qcdr-mipsmentioning

confidence: 99%

Preliminary Results of the Outpatient Endovascular and Interventional Society National Registry

et al. 2020

View full text Add to dashboard Cite

Purpose To present a new outcomes-based registry to collect data on outpatient endovascular interventions, a relatively new site of service without adequate historical data to assess best clinical practices. Quality data collection with subsequent outcomes analysis, benchmarking, and direct feedback is necessary to achieve optimal care. Materials and Methods The Outpatient Endovascular and Interventional Society (OEIS) established the OEIS National Registry in 2017 to collect data on safety, efficacy, and quality of care for outpatient endovascular interventions. Since then, it has grown to include a peripheral artery disease (PAD) module with plans to expand to include cardiac, venous, dialysis access, and other procedures in future modules. As a Qualified Clinical Data Registry approved by the Centers for Medicare and Medicaid Services, this application also supports new quality measure development under the Quality Payment Program. All physicians operating in an office-based laboratory or ambulatory surgery center can use the Registry to analyze de-identified data and benchmark performance against national averages. Major adverse events were defined as death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery. Results Since Registry inception in 2017, 251 participating physicians from 64 centers located in 18 states have participated. The current database includes 18,134 peripheral endovascular interventions performed in 12,403 PAD patients (mean age 72.3±10.2 years; 60.1% men) between January 2017 and January 2020. Cases were performed primarily in an office-based laboratory (85.1%) or ambulatory surgery center setting (10.4%). Most frequently observed procedure indications from 16,086 preprocedure form submissions included claudication (59%), minor tissue loss (16%), rest pain (9%), acute limb ischemia (5%), and maintenance of patency (3%). Planned diagnostic procedures made up 12.2% of cases entered, with the remainder indicated as interventional procedures (87.6%). The hospital transfer rate was 0.62%, with 88 urgent/emergent transfers and 24 elective transfers. The overall complication rate for the Registry was 1.87% (n=338), and the rate of major adverse events was 0.51% (n=92). Thirty-day mortality was 0.03% (n=6). Conclusion This report describes the current structure, methodology, and preliminary results of OEIS National Registry, an outcomes-based registry designed to collect quality performance data with subsequent outcome analysis, benchmarking, and direct feedback to aid clinicians in providing optimal care.

show abstract

“…The pacing was performed by stimulating the diaphragm through daily therapy sessions, with the intention of exercising and rehabilitating the diaphragm muscle and with the objective of accelerating the process of liberation from mechanical ventilation. A multicenter, randomized, controlled, and open-label interventional study [192] will carry out (ClinicalTrials.gov Identifier NCT03096639) to investigate the safety and effectiveness of a temporary transvenous diaphragm pacing (TTVDP). The aim is 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.…”

Section: Potential Therapeutical Approaches For Viddmentioning

confidence: 99%

“…The majority of critically ill patients admitted to the ICU require mechanical ventilation, and a substantial amount of time spent in the ICU is dedicated to withdrawal from the ventilator [1–3]. It is during the weaning process that diaphragmatic function becomes so important, as it is a major determinant of weaning success and clinical outcomes [192].…”

Section: Future Directionsmentioning

confidence: 99%

Ventilator-induced diaphragm dysfunction: translational mechanisms lead to therapeutical alternatives in the critically ill

Peñuelas

Keough

López‐Rodríguez

et al. 2019

ICMx

View full text Add to dashboard Cite

Mechanical ventilation [MV] is a life-saving technique delivered to critically ill patients incapable of adequately ventilating and/or oxygenating due to respiratory or other disease processes. This necessarily invasive support however could potentially result in important iatrogenic complications. Even brief periods of MV may result in diaphragm weakness [i.e., ventilator-induced diaphragm dysfunction [VIDD]], which may be associated with difficulty weaning from the ventilator as well as mortality. This suggests that VIDD could potentially have a major impact on clinical practice through worse clinical outcomes and healthcare resource use. Recent translational investigations have identified that VIDD is mainly characterized by alterations resulting in a major decline of diaphragmatic contractile force together with atrophy of diaphragm muscle fibers. However, the signaling mechanisms responsible for VIDD have not been fully established. In this paper, we summarize the current understanding of the pathophysiological pathways underlying VIDD and highlight the diagnostic approach, as well as novel and experimental therapeutic options.

show abstract

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

Cited by 22 publications

References 66 publications

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

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

Preliminary Results of the Outpatient Endovascular and Interventional Society National Registry

Ventilator-induced diaphragm dysfunction: translational mechanisms lead to therapeutical alternatives in the critically ill

Contact Info

Product

Resources

About