Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

NCT04680351 | Unknown

• 1 other identifier: 49RC20_0270
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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 Arms (1)

phrenic stimulation

EXPERIMENTAL

Procedure: phrenic stimulation

Interventions

phrenic stimulation PROCEDURE

measurements of the hemodynamic effects of phrenic stimulation

phrenic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient included in RESCUE 3 study, interventional arm with phrenic stimulation
• Patient or family consent

You may not qualify if:

• Patient not affiliated or not benefiting from a social security scheme

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (3)

CHU Angers

Angers, France

Location

APHP La Pitié-Salpêtrière

Paris, France

Location

APHP La Pitié-Salpêtrière

Paris, France

Location

Central Study Contacts

Marie LEMERLE

CONTACT

0241353637; marie.lemerle@chu-angers.fr

DRCI Promotion Interne

CONTACT

0241353637; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 23, 2020
• Study Start: March 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)