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Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

NCT ID: NCT04680351

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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phrenic stimulation

Group Type EXPERIMENTAL

phrenic stimulation

Intervention Type PROCEDURE

measurements of the hemodynamic effects of phrenic stimulation

Interventions

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phrenic stimulation

measurements of the hemodynamic effects of phrenic stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient included in RESCUE 3 study, interventional arm with phrenic stimulation
* Patient or family consent

Exclusion Criteria

* Patient not affiliated or not benefiting from a social security scheme
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status

APHP La Pitié-Salpêtrière

Paris, , France

Site Status

APHP La Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Central Contacts

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Marie LEMERLE

Role: CONTACT

Phone: 0241353637

Email: [email protected]

DRCI Promotion Interne

Role: CONTACT

Phone: 0241353637

Email: [email protected]

Facility Contacts

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Marie LEMERLE

Role: primary

Alexandra BEURTON

Role: primary

Martin DRES

Role: primary

Other Identifiers

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49RC20_0270

Identifier Type: -

Identifier Source: org_study_id