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Ultrasound Diaphragmatic Thickening to Monitor Its Dysfunction in Patients With Sepsis (US-Diamonds)

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ClinicalTrials.gov Identifier: NCT02474797
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief 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.


Condition or disease Intervention/treatment Phase
Sepsis Disease of Diaphragm Defect of Diaphragm Intensive Care Neuropathy Device: Diaphragmatic ultrasonography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Collection of potential risk factors: age, sex, tobacco, alcohol, cirrhosis, diabetes mellitus [ Time Frame: At baseline ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient hospitalized in our Medical/Surgical ICU;
  • Severe sepsis of septic shock (2001 International Sepsis Definition Conference);
  • Age > 18 years;
  • Patient consent.

Exclusion Criteria:

  • Preexisting neuromuscular disorders;
  • Recent cardiac or thoracic surgery;
  • Use of neuromuscular blocking agent within the 24h preceding the first diaphragm assessment;
  • Known preexisting diaphragmatic disorders;
  • Cervical spine injury;
  • Refusal to participate.

Information from the National Library of Medicine

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


Locations
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France
Groupe Hospitalier Paris Saint-Joseph
Paris, Ile De France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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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

Publications:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02474797    
Other Study ID Numbers: 2014-A01942-45
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Ultrasonography
Diaphragm
Lung ultrasound
Sepsis
Critical care
Chest physiotherapy
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes