Ultrasound Diaphragmatic Thickening to Monitor Its Dysfunction in Patients With Sepsis

Summary

Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim of this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction frequency, its prognosis value and its associated factors.

This is a prospective pilot study in a 14-bed medical and surgical ICU including 50 consecutive patients with severe sepsis or septic shock. The expected duration of study is 18 months.

DTF is measured each day as follow: the probe is placed in an intercostal space between mid axillary line and anterior axillary line, 0.5cm to 2 centimeters below the costodiaphragmatic sinus. DTF measure is performed in B-mode using the following formula: TF (%) = \[(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100\]. A DTF \< 20% indicates a diaphragmatic dysfunction.

The investigators will collect potential factors for which DTF Ultrasound Measure could have a prognosis value (intubation, successful or failed weaning from mechanical ventilation), potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors.

The investigators expect measure of DTF allows identifying patient with severe sepsis or septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic dysfunction frequency with ultrasound measure and warranting its use routinely at the bedside. The investigators expect that DTF helps to characterize degree of severity of septic patient and can be a new index able to predict intubation in this population.

Conditions

• Sepsis
• Disease of Diaphragm
• Defect of Diaphragm
• Intensive Care Neuropathy

Interventions

DEVICE

Diaphragmatic ultrasonography

Daily Measure of Diaphragmatic Thickening Fraction (DTF) will be performed by a trained physiotherapist. Physiotherapist (A. LE NEINDRE). The patient will be then instructed to perform breathing to total lung capacity and then to exhale to residual volume, when it is possible (awaken patient). Awakening status will be recorded. Mechanically ventilated patients will be evaluated in Pressure Support (PS) mode (during daily PS mode research for patients with Controlled Ventilation), with the lower PS level tolerated. PS level will be recorded. Thickening fraction (TF) measure is performed in B-mode using the following formula: TF (%) = \[(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100\]. Diaphragmatic dysfunction is defined like a DTF \< 20% (7).

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph

  lead OTHER

Principal Investigators

• Aymeric Le Neindre, PT, MSc · Fondation Hôpital Saint-Joseph

• François Philippart, MD, PhD · Fondation Hôpital Saint-Joseph

• Benoît Misset, MD, PhD · Fondation Hôpital Saint-Joseph

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-04

Primary Completion

2019-07-08

Completion

2020-04-01

Countries

• France

Study Locations