An observational study in Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational
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.
This procedure will be repeated 1-3 times over seven days with at least 24 hours between each measurement
Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Difficult to wean, mechanically ventilated patients
Exclusion Criteria:
Inspiratory muscle training at no load, and at 15, 25, 35 and 45% participants maximal inspiratory pressure
Diaphragmatic muscle activation (measured by electromyography)
At rest and at each IMT load on each study occasion
Time frame: 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
Time frame: Up to 7 days
Perceived difficultly and unpleasantness (number rating scale 0-10)
At each IMT load on each study occasion
Time frame: 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
Time frame: Up to 7 days
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Royal Brompton & Harefield NHS Foundation Trust