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Clinical Trials/NCT04680351
NCT04680351
Unknown
Not Applicable

Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

University Hospital, Angers2 sites in 1 country10 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
University Hospital, Angers
Enrollment
10
Locations
2
Primary Endpoint
measurement of integral time speed by cardiac transthoracic ultrasound
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
April 1, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

measurement of integral time speed by cardiac transthoracic ultrasound

Time Frame: 1 minute

to assess the effects of phrenic stimulation on cardiac output

Measurement of increased venous return gradient in percentage (variation between the value before phrenic stimulation and the value after phrenic stimulation)

Time Frame: 1 minute

To specify the mechanisms of the effect of phrenic stimulation on cardiac output

Secondary Outcomes

  • variation in ventilation distribution before and after phrenic stimulation measured in electrical impedance tomography(1 minute)
  • Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique(1 minute)

Study Sites (2)

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