HEMOSTIM: Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

Sponsor
University Hospital, Angers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04680351
Collaborator
(none)
10
3
1
25
3.3
0.1

Study Details

Study Description

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
  • Procedure: phrenic stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: phrenic stimulation

Procedure: phrenic stimulation
measurements of the hemodynamic effects of phrenic stimulation

Outcome Measures

Primary Outcome Measures

  1. measurement of integral time speed by cardiac transthoracic ultrasound [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) [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 [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 [1 minute]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU Angers Angers France
2 APHP La Pitié-Salpêtrière Paris France
3 APHP La Pitié-Salpêtrière Paris France

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04680351
Other Study ID Numbers:
  • 49RC20_0270
First Posted:
Dec 23, 2020
Last Update Posted:
Dec 23, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 23, 2020