Muscle Ultrasound Study in Shock Patients

Completed

• Conditions: Septic Shock
• Interventions: Other: Diaphragm ultrasound (DUS); Other: Peripheral Muscle Ultrasound (PMUS); Other: Airway occlusion pressure (P0.1); Other: Medical Research Council (MRC) sum score

• Registration Number: NCT04550143
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Study Start: 2020-10-13
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic Shock	Peripheral Muscle Ultrasound (PMUS)	-
Septic Shock	Airway occlusion pressure (P0.1)	-
Septic Shock	Diaphragm ultrasound (DUS)	-
Septic Shock	Medical Research Council (MRC) sum score	-

Primary Outcome Measures

Name	Time	Method
Association between SWE assessment and other muscle ultrasound markers.	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.

Secondary Outcome Measures

Name	Time	Method
Association between the rate change (%) in DUS and PMUS assessments.	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.
Weaning success/failure predictive model.	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.

Trial Locations

Locations (1)

Service de Soins Intensifs, Hôpitaux Universitaires de Genève (HUG); 🇨🇭 Geneva, Switzerland