Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation

Not Applicable

• Conditions: Mechanical Ventilation
• Interventions: Procedure: phrenic stimulation

• Registration Number: NCT04680351
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-17
• Last Update Submitted: 2020-12-17
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23
• Study Start: 2021-03-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
phrenic stimulation	phrenic stimulation	-

Primary Outcome Measures

Name	Time	Method
measurement of integral time speed by cardiac transthoracic ultrasound	1 minute	to assess the effects of phrenic stimulation on cardiac output
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

Name	Time	Method
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
Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique	1 minute

Trial Locations

Locations (2)

CHU Angers; 🇫🇷 Angers, France

APHP La Pitié-Salpêtrière; 🇫🇷 Paris, France