CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Diaphragmatic ultrasonographydevice
Likely dose
Not stated in record
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Search/NCT02474797
NCT02474797N/ACompleted

Assessment of Diaphragmatic Function by Ultrasonographic Measure of Diaphragmatic Thickening in Severe Sepsis or Septic Shock Patients Hospitalized in ICU: Diaphragmatic Dysfunction Frequency, Prognosis Values and Associated Factors

Fondation Hôpital Saint-Joseph·interventional·Posted Jun 18, 2015·Updated May 1, 2020

In Brief

A clinical study evaluating Diaphragmatic ultrasonography for Sepsis and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 18, 2015
Enrollment StartMay 4, 2015
Primary CompletionJul 8, 2019
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.0 years ago

Interventions

Diaphragmatic ultrasonographydevice

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).