TY - JOUR
T1 - Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation
T2 - Study protocol for a randomized trial 11 Medical and Health Sciences 1103 Clinical Sciences
AU - Evans, Douglas
AU - Shure, Deborah
AU - Clark, Linda
AU - Criner, Gerard J.
AU - Dres, Martin
AU - De Abreu, Marcelo Gama
AU - Laghi, Franco
AU - McDonagh, David
AU - Petrof, Basil
AU - Nelson, Teresa
AU - Similowski, Thomas
N1 - Funding Information:
The authors are grateful to Mr. Jean Allard for designing Fig. 2 The RESCUE 2 study is entirely funded by Lungpacer, Inc. The study sponsor originated the study and contributed to the study design with help of a scientific advisory board constituted for this purpose. The study sponsor will be responsible for data collection, management, and analysis that will be subcontracted to established professional companies (CRO for data collection and management). The study sponsor and the investigators will have full access to the final trial dataset; there are no contractual agreements that limit such access for investigators. The study sponsor will have a consultative role in the writing of the report that will be tasked to a writing committee comprising the investigators. The study sponsor will be involved in the decision to submit the report for publication, without ultimate authority.
Funding Information:
The RESCUE 2 study will be the first controlled study of temporary transvenous diaphragm pacing (TTVDP) in patients who are difficult to wean from MV, a highly relevant clinical challenge. It will be the first study to specifically address VIDD as the cause of weaning failure and to test the hypothesis that TTVDP can accelerate difficult weaning from MV. This hypothesis is supported by the likely pathophysiological role of ICU-acquired diaphragmatic dysfunction in difficult-to-wean patients and by the known capacity of diaphragm pacing to correct diaphragmatic disuse atrophy in long-term MV-dependent patients with quadriplegia.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/1/17
Y1 - 2019/1/17
N2 - 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.
AB - 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.
KW - Diaphragm
KW - Mechanical ventilation
KW - Phrenic stimulation
KW - Ventilator-induced diaphragmatic dysfunction
KW - Weaning
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UR - http://www.scopus.com/inward/citedby.url?scp=85060146375&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-3171-9
DO - 10.1186/s13063-018-3171-9
M3 - Article
C2 - 30654837
AN - SCOPUS:85060146375
VL - 20
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 60
ER -