Ultrasound Diaphragmatic Thickening to Monitor Its Dysfunction in Patients With Sepsis

NCT02474797 | Completed

• 1 other identifier: 2014-A01942-45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ultrasonography; Diaphragm; Lung ultrasound; Sepsis; Critical care; Chest physiotherapy

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic Dysfunction with DTF Ultrasound measure

  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.

  Participants will be followed for the duration of ICU stay, an expected average of 10 days

Secondary Outcomes (4)

• Collection of potential factors for which DTF Ultrasound Measure could have a prognosis value: intubation, successful or failed weaning from mechanical ventilation

  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

  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

  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

  Participants will be followed for the duration of ICU stay, an expected average of 10 days

Study Arms (1)

Diaphragmatic ultrasonography in septic patient

EXPERIMENTAL

Diaphragmatic Thickening Fraction

Device: Diaphragmatic ultrasonography

Interventions

Diaphragmatic ultrasonography DEVICE

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).

Also known as: Diaphragmatic sonography

Diaphragmatic ultrasonography in septic patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (7)

• Jung B, Nougaret S, Conseil M, Coisel Y, Futier E, Chanques G, Molinari N, Lacampagne A, Matecki S, Jaber S. Sepsis is associated with a preferential diaphragmatic atrophy: a critically ill patient study using tridimensional computed tomography. Anesthesiology. 2014 May;120(5):1182-91. doi: 10.1097/ALN.0000000000000201.

  PMID: 24608360 BACKGROUND

• Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.

  PMID: 23786764 BACKGROUND

• Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.

  PMID: 23641946 BACKGROUND

• Santos PD, Teixeira C, Savi A, Maccari JG, Neres FS, Machado AS, de Oliveira RP, Ribeiro M, Rotta FT. The critical illness polyneuropathy in septic patients with prolonged weaning from mechanical ventilation: is the diaphragm also affected? A pilot study. Respir Care. 2012 Oct;57(10):1594-601. doi: 10.4187/respcare.01396. Epub 2012 Mar 13.

  PMID: 22417531 BACKGROUND

• Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.

  PMID: 17316468 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Summerhill EM, El-Sameed YA, Glidden TJ, McCool FD. Monitoring recovery from diaphragm paralysis with ultrasound. Chest. 2008 Mar;133(3):737-43. doi: 10.1378/chest.07-2200. Epub 2008 Jan 15.

  PMID: 18198248 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aymeric Le Neindre, PT, MSc

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

• François Philippart, MD, PhD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

• Benoît Misset, MD, PhD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 18, 2015
• Study Start: May 4, 2015
• Primary Completion: July 8, 2019
• Study Completion: April 1, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

FR (1)