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

December 17, 2020 updated by: University Hospital, Angers

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: phrenic stimulation
Procedure: phrenic stimulation
measurements of the hemodynamic effects of phrenic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of integral time speed by cardiac transthoracic ultrasound
Time Frame: 1 minute
to assess the effects of phrenic stimulation on cardiac output
1 minute
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
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute
Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique
Time Frame: 1 minute
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 49RC20_0270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mechanical Ventilation

Clinical Trials on phrenic stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe