Muscle Ultrasound Study in Shock Patients (MUSiShock)

December 4, 2024 updated by: Karim Bendjelid, University Hospital, Geneva

Diaphragm Dysfunction and Peripheral Muscle Wasting in Septic Shock Patients: Exploring Their Relationship Over Time Using Ultrasound Technology

Intensive Care Unit (ICU) patients are known to lose muscle mass and function for many reasons, ranging from prolonged immobilization, to the effects of ICU treatments such as mechanical ventilation (MV), to the critical illness itself. Ultrasonography (US) is widely used in the ICU setting and has greatly evolved in the last decades, since it allows the non-invasive assessment of different structures, using radiation-free and user-friendly technology; its application for the assessment or the skeletal muscle is a promising tool and might help detecting muscle changes and thus several dysfunctions during early stages of ICU stay.

By using skeletal muscle ultrasound at both diaphragm and peripheral levels, the overall aim of this study is to improve knowledge in the early detection of muscle dysfunction and weakness , and their relationship with mechanical ventilation weaning and muscle strength, in critically ill patients suffering from septic shock.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Service de Soins Intensifs, Hôpitaux Universitaires de Genève (HUG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This research project will include any adult patient (> 18 years old) admitted to the ICU (University Hospitals of Geneva, HUG) with a diagnosis of septic shock, respecting the pre-defined inclusion and exclusion criteria. No restrictions will be applied to the source of infection.

Description

Inclusion Criteria:

  1. adult patients (> 18 years old) admitted to the ICU
  2. with a diagnosis of septic shock
  3. a SOFA score equal or superior to 8 points, at ICU admission
  4. blood lactate concentration above 2 mmol/L, at ICU admission
  5. expected to have more than 48h of mechanical ventilation (estimated by the attending physician)
  6. expected to stay more than 5 days in the unit (estimated by the attending physician)
  7. able to walk prior to ICU admission / walking aids accepted;

Exclusion Criteria:

  1. pregnancy
  2. lower limb amputation, fixators or open wounds
  3. thoracic fixators or open wounds
  4. diagnosed neuromuscular or central nervous system diseases
  5. being transferred from another ICU
  6. spinal cord injury
  7. diaphragm pacemaker
  8. palliative goals of care
  9. cancers derived sarcopenia
  10. cachexia
  11. anorexic disorders (protein-energy malnutrition)
  12. intellectual or cognitive impairments, limiting the ability to follow instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Septic Shock
Other: Diaphragm ultrasound (DUS)

DUS assessments of diaphragmatic thickness (TDI), thickness fraction (TFDI) and shear modulus (SMDI), this last measured by shear-wave elastography (SWE), will be performed for both right and left hemi-diaphragms.

A landmark between the 8th and 10th intercostal space in the mid-axillary or antero-axillary line, 0.5-2 cm below the costophrenic sinus, will be used. Here, the diaphragm can be seen as the less echogenic structure between two echogenic lines; TDI (cm) will be the calculated as the distance between the two lines at the end of expiration and TFDI as the rate of change between end-expiration and end-inspiration thicknesses (TFDI = "thickness at end inspiration" - "thickness at end-expiration" / "thickness at end-expiration", %).

SMDI will assess muscle's stiffness. For each image, a region of interest covering the widest possible surface of diaphragm and allowing an acquisition frequency of 2Hz will be set; results will be retrieved in kilopascals (kPa).

Other Names:
  • Diaphragm ultrasonography
Other: Peripheral Muscle Ultrasound (PMUS)

PMUS assessments of quadriceps rectus femoris (RF) muscle cross-sectional area (CSARF), echogenicity (ECHORF) and shear modulus (SMRF), this last measured by shear-wave elastography (SWE), will be performed.

Probe will be placed perpendicularly to the anterior plane of the thigh, in 2 anatomical points, as follows:

(i) in the midpoint between the anterior superior iliac spine and the upper pole of the patella and (ii) the border of the lower 1/3 and upper 2/3 between the anterior superior iliac spine and the upper pole of the patella.

CSARF (cm2) will be calculated by outlining the area under the muscle hyperechoic line (aponeurosis). For ECHORF (differences in grey-scale images), the analysis of a region of interest (ROI) of 2cm x 2cm will be performed.

For SMRF (kPa), a ROI covering the widest possible area of the RF and allowing an acquisition frequency of 2Hz will be set for analysis.

All assessments will be performed with minimal compression and a copious amount of water-gel.

Other Names:
  • Muscle ultrasonography
Other: Airway occlusion pressure (P0.1)

P0.1 is "the pressure developed in the occluded airway 100 milliseconds after the onset of inspiration". Its use doesn't require any additional equipment since it can be easy measured by using patient's ventilator.

For the measurement itself, patients will be in semi-recumbent position (head elevation between 30° and 45°) with knee extended in neutral position and will be asked to stay as relaxed as possible. After 5 minutes breathing without any interruption or disturbance, 4 measurements will be observed and recorded as displayed on the ventilator screen.

Other: Medical Research Council (MRC) sum score

This is a manual muscle strength testing tool, used very often in the ICU setting. It's based on the assessment of the following muscle groups: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and dorsiflexion of the ankle, all scored bilaterally. Muscle strength is graded as follows: 0, "no visible/palpable contraction"; 1, "visible/palpable contraction without movement of the limb"; 2, "movement of the limb, but not against gravity"; 3, "movement against gravity"; 4, "movement against gravity and some resistance"; 5, "normal".

The sum score ranges between 0 and 60 (between 0 and 5, in 12 muscle groups), with a score <48 indicating the presence of weakness.

Other Names:
  • MRC muscle strength score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Baseline (at 24 hours after ICU admission)
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Baseline (at 24 hours after ICU admission)
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Day 2, after ICU admission
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Day 2, after ICU admission
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Day 3, after ICU admission
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Day 3, after ICU admission
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Day 4, after ICU admission
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Day 4, after ICU admission
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Day 5, after ICU admission
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Day 5, after ICU admission
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Extubation day, approximately 7 days
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Extubation day, approximately 7 days
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: Weekly (1x/week), counting from day 6 of ICU stay until ICU discharge (approximately 10 days)
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Weekly (1x/week), counting from day 6 of ICU stay until ICU discharge (approximately 10 days)
Association between SWE assessment and other muscle ultrasound markers.
Time Frame: ICU discharge, approximately 10 days
To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
ICU discharge, approximately 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between the rate change (%) in DUS and PMUS assessments.
Time Frame: Time-points of assessment relating to baseline (ICU admission) values.
The association between the rate change (%) in DUS (TDI, TFDI and SMDI) and PMUS (CSARF, ECHORF and SMRF) markers over time, during the ICU stay, in adult patients (> 18 years old) admitted for a septic shock.
Time-points of assessment relating to baseline (ICU admission) values.
Weaning success/failure predictive model.
Time Frame: Between ICU admission and extubation moment.
The analysis of a combined model comprising, among other ICU variables, one DUS marker (TDI, TFDI and SMDI) and one PMUS marker (CSARF, ECHORF and SMRF) to predict weaning success/failure, in adult patients (> 18 years old) admitted to the ICU for a septic shock.
Between ICU admission and extubation moment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Karim Bendjelid, MD, PhD, Hôpitaux Universitaires de Genève (HUG) / Université de Genève (UNIGE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

August 20, 2024

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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