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Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation (HEMOSTIM)

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ClinicalTrials.gov Identifier: NCT04680351
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Procedure: phrenic stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: phrenic stimulation Procedure: phrenic stimulation
measurements of the hemodynamic effects of phrenic stimulation


Outcome Measures
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Primary Outcome Measures :
  1. measurement of integral time speed by cardiac transthoracic ultrasound [ Time Frame: 1 minute ]
    to assess the effects of phrenic stimulation on cardiac output

  2. 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 Outcome Measures :
  1. variation in ventilation distribution before and after phrenic stimulation measured in electrical impedance tomography [ Time Frame: 1 minute ]
    To assess the effects of diaphragmatic stimulation on ventilation and pulmonary recruitment measured in electrical impedance tomography

  2. Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique [ Time Frame: 1 minute ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680351


Contacts
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Contact: Marie LEMERLE 0241353637 marie.lemerle@chu-angers.fr
Contact: DRCI Promotion Interne 0241353637 DRCI-Promotion-Interne@chu-angers.fr

Locations
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France
CHU Angers
Angers, France
Contact: Marie LEMERLE       marie.lermerle@chu-angers.fr   
APHP La Pitié-Salpêtrière
Paris, France
Contact: Alexandra BEURTON       alexandra.beurton@aphp.fr   
APHP La Pitié-Salpêtrière
Paris, France
Contact: Martin DRES       martin.dres@aphp.fr   
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04680351    
Other Study ID Numbers: 49RC20_0270
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No