Characterising Changes in Muscle Quantity and Quality in Patients Requiring ECMO Oxygen During Critical Illness

NCT02995811 | Completed

• 1 other identifier: 208134
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study will identify the changes in different muscles of patients receiving Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive Care Unit (ICU). The information will help guide development of treatments such as exercise that may help to reduce the amount of muscle wasting that can occur during critical illness.

Conditions

Critical Illness; Intensive Care Units; Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (2)

• Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound

  10 days

• Sequential changes in quality of the muscles in critically ill patients requiring ECMO by Ultrasound

  10 Days

Study Arms (1)

Observational Cohort

* On Days 1, 3, 7 and 10 of ICU admission, patients will undergo ultrasound assessment of the diaphragm, transverse and rectus abdominis, quadriceps rectus femoris, and tibialis anterior muscles. Imaging all four muscles together requires approximately 1 hour. * Physical activity monitoring: On Days 1-10 of ICU admission patients will wear an activity monitor. These devices use several inertial motion sensors to track the movement and acceleration of the limbs in horizontal and vertical directions. * Patients will also undergo daily assessment of global peripheral skeletal muscle strength assessed by the Medical Research Council Sum-score and global function measured by the Chelsea Critical Care Physical Assessment Scale

Other: Observational Cohort

Interventions

Observational Cohort OTHER

Ultrasound assessment of 4 muscles, activity monitoring, daily global peripheral skeletal muscle strength

Observational Cohort

Eligibility Criteria

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

Study Population

Adult critically ill patients admitted to the ICU with critical illness requiring ECMO

You may qualify if:

• Adult, ≥18years
• Requiring ECMO for management of severe respiratory failure
• Likely to remain in the ICU for 10days

You may not qualify if:

• Pregnancy
• Neurological injury e.g. stroke, acquired brain injury
• Trauma injury e.g. amputation, multiple fractures
• Clinical presentation precluding ultrasound imaging of muscle at the time of assessment
• Not expected to survive more than 24 hours

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Euro-ELSO: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Barrett

  Guy's and St Thomas' NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 16, 2016
• Study Start: November 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: February 7, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)