Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04680351
Status:
UNKNOWN
Last Update Posted:
2020-12-23
First Post:
2020-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMOSTIM
Brief Summary:
Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Mechanical ventilation also has effects on the diaphragm: diaphragmatic dysfunction. It is explained by a prolonged inactivity of this muscle with a reduction of muscle fibers that can settle down quickly, after only a few days of mechanical ventilation. This dysfunction results in a reduction in the latter's ability to generate intrathoracic pressure necessary for ventilation, slows the withdrawal of mechanical ventilation and lengthens the duration of stay in intensive care unit. To reduce this dysfunction, phrenic stimulation has been proposed as an alternative to remuscler the diaphragm thanks to electrodes located on a central venous catheter, also used to deliver the usual therapies in intensive care unit.
The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.
The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: