Critical IllnessNCT07110129
Using sEMG of the Diaphragm to Assess Readiness for Extubation
An observational study of Critical Illness, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to critical care for level 3 support
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiff and Vale University Health Board
Cardiff, CF144XW
Paul Twose, 00447739315830, paul.twose@wales.nhs.uk
About this study
Official title: Using sEMG of the Diaphragm to Assess Readiness for Extubation - Feasibility Study to Design a Pragmatic Multi-site Trial Protocol
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.
Read more
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.
Read the detailed description
150,000 patients a year in the UK need to be admitted to a critical care unit. Those admitted are usually either critically unwell or are in the recovery phase of a critical illness (1). Often patients will require support for one or more of their vital organs such as their lungs, heart or kidneys. Approximately 60% of patients admitted will require support from mechanical ventilation (breathing machine) (2).
Mechanical ventilation is lifesaving when indicated but is beset by potential complications as the duration increases (3). Early identification of patients who are ready to be liberated from ventilatory support is therefore key. However, clinician judgement lacks both sensitivity and specificity for identifying such patients.
A Cochrane review in 2010 (4) demonstrated protocolised and standardised weaning method reduced the duration of total mechanical ventilation by 25%, weaning duration time by 78% and Intensive Care Unit (ICU) length of stay by 10%. Conversely, prolonged weaning process worsens patient outcomes, increases the risk of dying, and increases length of ICU and hospital stay, affects finite critical care resource and a direct impact on financial cost and environment sustainability (5).
Predicting readiness for extubation is challenging. This task is best accomplished by means of a protocolised process including a spontaneous awakening trial (SAT) where sedation is lowered to a safe RASS target and a spontaneous-breathing trials (SBT), in which patients who meet a defined set of criteria undergo a test period of minimal (Pressure support ventilation) or no ventilator (T-piece) support (6). This is then frequently combined with objective markers or 'extubation indices'. These indices include assessments of breathing strength and endurance, cough strength and respiratory distress e.g., P0.1, MIP, Peak cough flow and RSBI. However, these indices have been shown to lack sensitivity and specificity, with none of them able to accurately predict readiness for extubation or likely success (7).
The incidence of extubation failure reported in literature is quite variable with ~5% in post-operative surgical units to 10% in medical ICUs. With each additional day without a weaning success after the first attempt, there is an associated increase in crude mortality. Crude mortality increased from 19.0% in patients not weaned one day after the first attempt to 36.8% in patients still present in the ICU and not successfully weaned 10 days after the first attempt (8). Studies have also demonstrated that patients requiring reintubation are at increased risk of death with mortality rates ranging as high as 43% compared with less than 12% in patients successfully extubated (9). Reintubation is associated with a 4.5 times increased risk of nosocomial pneumonia (10).
Therefore, identifying new methods for determine likelihood for successful extubation is of clinical importance. Once such 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 (11). However, until recently measuring diaphragm activity has been a challenge due to noise from the chest movements, cardiac artifacts. Recent advancements in signal processing and growing interest in better diagnostic methods has led to an improvement in metrics (12). Using wavelet transforms and machine learning, new techniques have been developed to measure diaphragm muscle activity using surface EMG electrodes placed at the 6-8th intercostal space along the mid-axillary or mid-clavicular line (13). Indeed, a pilot study looking at the sEMG of the diaphragm in healthy humans has shown that we are able to predict the inspiratory load of 6 participants with over 70% accuracy. sEMG has also been shown to be effective in detecting patient-ventilator asynchrony as well as respiratory strength in those not requiring mechanical ventilation (14). 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
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critical care cohort | Critical care cohort - all to have EMG completed. No other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment and retention of participants
To determine study feasibility by recruitment and retention rates from study participants across a single site
Measured: 1 year
Secondary outcomes (1)
Appropriateness of use of EMG for diaphragm strength
To determine the appropriateness of sEMG in assessing diaphragm strength in relation to extubation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110129
- Sponsor's protocol ID
- 8999
- Other IDs
- IRAS 353832
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using sEMG of the Diaphragm to Assess Readiness for Extubation - Feasibility Study to Design a Pragmatic Multi-site Trial Protocol
- ClinicalTrials.gov ID
- NCT07110129
- Acronym / sponsor ID
- 8999
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
150,000 patients a year in the UK need to be admitted to a critical care unit. Those admitted are usually either critically unwell or are in the recovery phase of a critical illness (1). Often patients will require support for one or more of their vital organs such as their lungs, heart or kidneys. Approximately 60% of patients admitted will require support from mechanical ventilation (breathing machine) (2).
Mechanical ventilation is lifesaving when indicated but is beset by potential complications as the duration increases (3). Early identification of patients who are ready to be liberated from ventilatory support is therefore key. However, clinician judgement lacks both sensitivity and specificity for identifying such patients.
A Cochrane review in 2010 (4) demonstrated protocolised and standardised weaning method reduced the duration of total mechanical ventilation by 25%, weaning duration time by 78% and Intensive Care Unit (ICU) length of stay by 10%. Conversely, prolonged weaning process worsens patient outcomes, increases the risk of dying, and increases length of ICU and hospital stay, affects finite critical care resource and a direct impact on financial cost and environment sustainability (5).
Predicting readiness for extubation is challenging. This task is best accomplished by means of a protocolised process including a spontaneous awakening trial (SAT) where sedation is lowered to a safe RASS target and a spontaneous-breathing trials (SBT), in which patients who meet a defined set of criteria undergo a test period of minimal (Pressure support ventilation) or no ventilator (T-piece) support (6). This is then frequently combined with objective markers or 'extubation indices'. These indices include assessments of breathing strength and endurance, cough strength and respiratory distress e.g., P0.1, MIP, Peak cough flow and RSBI. However, these indices have been shown to lack sensitivity and specificity, with none of them able to accurately predict readiness for extubation or likely success (7).
The incidence of extubation failure reported in literature is quite variable with ~5% in post-operative surgical units to 10% in medical ICUs. With each additional day without a weaning success after the first attempt, there is an associated increase in crude mortality. Crude mortality increased from 19.0% in patients not weaned one day after the first attempt to 36.8% in patients still present in the ICU and not successfully weaned 10 days after the first attempt (8). Studies have also demonstrated that patients requiring reintubation are at increased risk of death with mortality rates ranging as high as 43% compared with less than 12% in patients successfully extubated (9). Reintubation is associated with a 4.5 times increased risk of nosocomial pneumonia (10).
Therefore, identifying new methods for determine likelihood for successful extubation is of clinical importance. Once such 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 (11). However, until recently measuring diaphragm activity has been a challenge due to noise from the chest movements, cardiac artifacts. Recent advancements in signal processing and growing interest in better diagnostic methods has led to an improvement in metrics (12). Using wavelet transforms and machine learning, new techniques have been developed to measure diaphragm muscle activity using surface EMG electrodes placed at the 6-8th intercostal space along the mid-axillary or mid-clavicular line (13). Indeed, a pilot study looking at the sEMG of the diaphragm in healthy humans has shown that we are able to predict the inspiratory load of 6 participants with over 70% accuracy. sEMG has also been shown to be effective in detecting patient-ventilator asynchrony as well as respiratory strength in those not requiring mechanical ventilation (14). 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical care cohort | – | –Critical care cohort - all to have EMG completed. No other intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to critical care for level 3 support
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of recruitment and retention of participants
Time frame: 1 year
To determine study feasibility by recruitment and retention rates from study participants across a single site
1 secondary outcome
Appropriateness of use of EMG for diaphragm strength
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Twose, PhD (+447739315830, paul.twose@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment and retention of participants (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.