Ultrasound Diaphragmatic Thickening to Monitor Its Dysfunction in Patients With Sepsis (US-Diamonds)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02474797|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : February 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Disease of Diaphragm Defect of Diaphragm Intensive Care Neuropathy||Device: Diaphragmatic ultrasonography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 4, 2015|
|Actual Primary Completion Date :||July 8, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Diaphragmatic ultrasonography in septic patient
Diaphragmatic Thickening Fraction
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).
Other Name: Diaphragmatic sonography
- Diaphragmatic Dysfunction with DTF Ultrasound measure [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 10 days ]Diaphragmatic dysfunction is defined by DTF < 20%. Frequency of diaphragmatic dysfunction is measured by the ratio of: number of patient with DTF < 20% during ICU hospitalization on total number of patients included.
- Collection of potential factors for which DTF Ultrasound Measure could have a prognosis value: intubation, successful or failed weaning from mechanical ventilation [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 10 days ]
- Collection of potential risk factors: age, sex, tobacco, alcohol, cirrhosis, diabetes mellitus [ Time Frame: At baseline ]
- Collection of potentials associated factors: medication (hypnotics, opioids, steroids, catecholamines), mechanical ventilation, presence of a septic shock, severity score (SOFA), ICU and Hospital Length of stay, ICU and Hospital mortality [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 10 days ]
- Change in Diaphragmatic Thickening Fraction with DTF Ultrasound measure [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 10 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474797
|Groupe Hospitalier Paris Saint-Joseph|
|Paris, Ile De France, France, 75014|
|Principal Investigator:||Aymeric Le Neindre, PT, MSc||Groupe Hospitalier Paris Saint Joseph|
|Principal Investigator:||François Philippart, MD, PhD||Groupe Hospitalier Paris Saint Joseph|
|Principal Investigator:||Benoît Misset, MD, PhD||Groupe Hospitalier Paris Saint Joseph|