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

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: Mechanical Ventilation
• Intervention / Treatment: Procedure: phrenic stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie LEMERLE; Phone Number: 0241353637; Email: marie.lemerle@chu-angers.fr
• Study Contact Backup: Name: DRCI Promotion Interne; Phone Number: 0241353637; Email: DRCI-Promotion-Interne@chu-angers.fr

Study Locations

• France
  • Angers, France
    • Chu Angers
    • Contact: Marie LEMERLE; Email: marie.lermerle@chu-angers.fr
  • Paris, France
    • APHP la Pitié-Salpêtrière

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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)	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	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		1 minute

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

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