Using sEMG of the Diaphragm to Assess Readiness for Extubation

NCT07110129 | Recruiting

• 2 other identifiers: 8999IRAS 353832
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

As part of an admission to an Intensive Care Unit (ICU) many patients have breathing tube inserted into their windpipe, also referred to as intubation . This is done for a variety of reasons which can include the need for invasive breathing support and to place the patient into a medically induced coma to allow their body to rest and be treated for the underlying cause of their deterioration. One the patient has started to recover from their illness, the process of removing the breathing tube (extubation) and stopping the breathing machine begins. Optimising this process and ensuring successful removal of the breathing tube is extremely important to optimise outcomes. Therefore, identifying new methods to determine the likelihood for successful extubation is of clinical significance. There are several markers of extubation readiness that clinicians can use to support their decision making discussed in the literature. A novel method is the use of respiratory muscle activity monitoring via sensory electromyogram (sEMG). sEMG has previously been shown to be useful to measure the strength and activity of muscles. However, until recently measuring diaphragm activity has been a challenge due to noise from the chest movements, cardiac artefacts. Recent advancements in signal processing and growing interest in better diagnostic methods has led to an improvement in metrics. Using wavelet transforms and machine learning, new techniques have been developed to measure diaphragm muscle activity using sEMG. sEMG has been shown to be effective in detecting patient-ventilator asynchrony as well as respiratory strength in those not requiring mechanical ventilation. However, its use in assessing patients nearing readiness for extubation has not been explored. Therefore, the purpose of this feasibility trial is to explore the use of sEMG in patients undergoing trials of extubation. The results of this study will be used to design a multi-site trial.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment and retention of participants

  To determine study feasibility by recruitment and retention rates from study participants across a single site

  1 year

Secondary Outcomes (1)

• Appropriateness of use of EMG for diaphragm strength

  1 year

Study Arms (1)

Critical care cohort

Critical care cohort - all to have EMG completed. No other intervention

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

Patients admitted to critical care for level 3 support

You may qualify if:

• Patients requiring mechanical ventilation for \>72 hours
• Patients who an attempt at extubation is planned
• Patients who are willing or able to give informed consent (Where consultee advice is sought, informed consent from the participant will be completed as soon as possible).

You may not qualify if:

• Aged under 18 years
• Patients admitted with traumatic or spontaneous brain injury
• Patients for who extubation is planned as a palliative process
• Contra-indication to using sEMG e.g., permanent or temporary pacemaker, internal or external cardiac defibrillator, skin lesions around site of electrode placement

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Cardiff and Vale University Health Board

Cardiff, CF144XW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Paul Twose, PhD

CONTACT

+447739315830; paul.twose@wales.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 31, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)