NCT02474797: US-Diamonds

Ultrasound Diaphragmatic Thickening to Monitor Its Dysfunction in Patients With Sepsis

Completed NA Last updated 1 May 2020

What this trial tests

NA trial testing Diaphragmatic ultrasonography in Sepsis in 50 participants. Completed in 1 April 2020.

Timeline

4 May 2015

Primary endpoint
8 July 2019

1 April 2020

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	50
Start date	4 May 2015
Primary completion	8 July 2019
Estimated completion	1 April 2020
Sites	1 location across France

Drugs / interventions tested

• Diaphragmatic ultrasonography

Conditions studied

• Sepsis — all drugs for Sepsis →
• Disease of Diaphragm — all drugs for Disease of Diaphragm →
• Defect of Diaphragm — all drugs for Defect of Diaphragm →
• Intensive Care Neuropathy — all drugs for Intensive Care Neuropathy →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, any sex, with Sepsis or Disease of Diaphragm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.