Difficult to Wean, Mechanically Ventilated Patients With a TracheostomyNCT07256821
Identifying the Optimal IMT Dose in ICU
An observational study of Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
200,000 adults are admitted to intensive care in the UK each year. Many of these patients need help with their breathing and are put on a machine called a ventilator. Research shows that many patients using a ventilator quickly develop weakness in their main breathing muscle, called the diaphragm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy
- What is being tested?
- Inspiratory Muscle Training
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Nov 2025to Jan 2027
- 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: Difficult to wean, mechanically ventilated patients
Who may be able to join
- Mechanically ventilated patients with a tracheostomy
- Aged ≥ 18 years
- Co-operative and able to participate in IMT.
- Informed consent or surrogate approval
Who cannot join
- Facial or skull fracture, or a bleeding disorder which would prohibit oesophageal catheter placement.
- Undrained pneumothorax/pneumomediastinum.
- Delirium or deep sedation that impedes the patient's ability to participate in study procedures
- Pregnancy
- Unlikely to survive, or consultant assessment that the patient is not appropriate.
- Wounds that prohibit EMG 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
Royal Brompton and Harefield Hospitals
Marlow, SL7 3AS
Timothy Jenkins, 020 7352 8121, timothy.jenkins4@nhs.net
About this study
Official title: A Prospective, Mixed Methods, Observational Study to Define a Diaphragm-focussed and Patient-acceptable Inspiratory Muscle Training (IMT) Load in Difficult to Wean, Mechanically Ventilated Patients
200,000 adults are admitted to intensive care in the UK each year. Many of these patients need help with their breathing and are put on a machine called a ventilator.
Research shows that many patients using a ventilator quickly develop weakness in their main breathing muscle, called the diaphragm. This weakness can cause a longer time on the ventilator, a longer hospital stay, and higher chances of health problems or death.
Read more
Inspiratory muscle training is a breathing exercise where the patient breathes against resistance through a small device (like breathing through a straw). It aims to improve the strength of the diaphragm and reduce how long patients are on the ventilator.
Why is this research needed?
Research shows that current breathing exercise programmes do not help patients come off the ventilator or go home quicker. This may be because these breathing exercises strengthen the wrong muscles (those in the chest and neck, that are not efficient). These exercises can also be distressing for patients.
What will be done in this research? This research aims to develop a breathing exercise programme that focusses on strengthening the diaphragm. We will also make sure patients do not find the breathing exercise too distressing.
This research will measure how the breathing muscles respond to four different levels of breathing exercise and ask patients to feedback on each level.
- At each breathing exercise level, the effort of the breathing muscles will be measured using a small tube inserted into the nostril and small sticky patches on the chest and neck. We aim to find the level where the diaphragm is being pushed to work hard but other muscles in the chest and neck are not.
- After each breathing exercise level patients will be asked how they found it - for example, easy, pleasant, scary.
This procedure will be repeated 1-3 times over seven days with at least 24 hours between each measurement
- Being tested
- Inspiratory Muscle Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Inspiratory muscle training at no load, and at 15, 25, 35 and 45% participants maximal inspiratory pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic muscle activation (measured by electromyography)
At rest and at each IMT load on each study occasion
Measured: Up to 7 days
Extra diaphragmatic muscle activity (surface electromyography of scalene, sternocleidomastoid and parasternal muscles)
At rest and at each IMT load on each study occasion
Measured: Up to 7 days
Perceived difficultly and unpleasantness (number rating scale 0-10)
At each IMT load on each study occasion
Measured: Up to 7 days
The experience of IMT using qualitative techniques including verbal and non-verbal (including written communication, picture and word boards)
At each IMT load on each study occasion
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start23 Nov 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult to Wean, Mechanically Ventilated Patients With a TracheostomyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256821
- Sponsor's protocol ID
- 25/WA/0242
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins TO, Polkey MI, McWilliams D, Kilbride C, MacBean V. Defining a diaphragm-focused and patient-acceptable inspiratory muscle training (IMT) load in difficult to wean, mechanically ventilated patients: a protocol for a prospective, mixed methods study. BMJ Open Respir Res. 2026 Jun 24;13(1):e004168. doi: 10.1136/bmjresp-2026-004168.
PubMed 42342294
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Mixed Methods, Observational Study to Define a Diaphragm-focussed and Patient-acceptable Inspiratory Muscle Training (IMT) Load in Difficult to Wean, Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT07256821
- Acronym / sponsor ID
- 25/WA/0242
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Dec 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.
200,000 adults are admitted to intensive care in the UK each year. Many of these patients need help with their breathing and are put on a machine called a ventilator.
Research shows that many patients using a ventilator quickly develop weakness in their main breathing muscle, called the diaphragm. This weakness can cause a longer time on the ventilator, a longer hospital stay, and higher chances of health problems or death.
Inspiratory muscle training is a breathing exercise where the patient breathes against resistance through a small device (like breathing through a straw). It aims to improve the strength of the diaphragm and reduce how long patients are on the ventilator.
Why is this research needed?
Research shows that current breathing exercise programmes do not help patients come off the ventilator or go home quicker. This may be because these breathing exercises strengthen the wrong muscles (those in the chest and neck, that are not efficient). These exercises can also be distressing for patients.
What will be done in this research? This research aims to develop a breathing exercise programme that focusses on strengthening the diaphragm. We will also make sure patients do not find the breathing exercise too distressing.
This research will measure how the breathing muscles respond to four different levels of breathing exercise and ask patients to feedback on each level.
- At each breathing exercise level, the effort of the breathing muscles will be measured using a small tube inserted into the nostril and small sticky patches on the chest and neck. We aim to find the level where the diaphragm is being pushed to work hard but other muscles in the chest and neck are not.
- After each breathing exercise level patients will be asked how they found it - for example, easy, pleasant, scary.
This procedure will be repeated 1-3 times over seven days with at least 24 hours between each measurement
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Difficult to wean, mechanically ventilated patients
Key inclusion criteria (4 listed)
- Mechanically ventilated patients with a tracheostomy
- Aged ≥ 18 years
- Co-operative and able to participate in IMT.
- Informed consent or surrogate approval
Key exclusion criteria (6 listed)
- Facial or skull fracture, or a bleeding disorder which would prohibit oesophageal catheter placement.
- Undrained pneumothorax/pneumomediastinum.
- Delirium or deep sedation that impedes the patient's ability to participate in study procedures
- Pregnancy
- Unlikely to survive, or consultant assessment that the patient is not appropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory muscle training at no load, and at 15, 25, 35 and 45% participants maximal inspiratory pressure | Other | – |
Primary outcome
Diaphragmatic muscle activation (measured by electromyography)
Time frame: Up to 7 days
At rest and at each IMT load on each study occasion
Extra diaphragmatic muscle activity (surface electromyography of scalene, sternocleidomastoid and parasternal muscles)
Time frame: Up to 7 days
At rest and at each IMT load on each study occasion
Perceived difficultly and unpleasantness (number rating scale 0-10)
Time frame: Up to 7 days
At each IMT load on each study occasion
The experience of IMT using qualitative techniques including verbal and non-verbal (including written communication, picture and word boards)
Time frame: Up to 7 days
At each IMT load on each study occasion
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 12 Jan 2026.
- Derived from this study: PubMed 42342294Jenkins TO, Polkey MI, McWilliams D, Kilbride C, MacBean V. Defining a diaphragm-focused and patient-acceptable inspiratory muscle training (IMT) load in difficult to wean, mechanically ventilated patients: a protocol for a prospective, mixed methods study. BMJ Open Respir Res. 2026 Jun 24;13(1):e004168. doi: 10.1136/bmjresp-2026-004168.
- Individual participant dataSharing planned: No
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 Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy, run by Royal Brompton & Harefield NHS Foundation Trust 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 4 inclusion and 6 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 12 Jan 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic muscle activation (measured by electromyography) (time frame: Up to 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07256821, which also lists 1 linked publication.
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 12 Jan 2026.