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Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

Ventilator-Induced Lung Injury Clinical Trial

Official title:
Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

Clinical Trial Summary

This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.

Clinical Trial Description

15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04457427
Study type Interventional
Source Synapse Biomedical
Contact
Status Withdrawn
Phase N/A
Start date December 2016
Completion date March 2022
View Details
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