Finding the best inspiratory muscle training dose for tracheostomy patients in the ICU
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
Run by Royal Brompton & Harefield NHS Foundation Trust · NCT07256821 · Data updated 2026-11-12
This trial tests different amounts of inspiratory muscle training to see if stronger breathing muscles help adults with a tracheostomy in the ICU come off ventilators faster.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Locations | 1 site (Marlow) |
| Status | Recruiting |
| Started | November 23, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07256821 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (aged 18 or older) who are mechanically ventilated with a tracheostomy, are cooperative and able to perform IMT, and can provide informed consent or have a surrogate who can consent.
✕Probably not a fit
Patients with facial or skull fractures or bleeding disorders preventing oesophageal catheter placement, undrained pneumothorax or pneumomediastinum, deep sedation or delirium that prevents participation, pregnancy, a prognosis judged unlikely to survive, or wounds preventing EMG placement are not suitable and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adults who are mechanically ventilated via tracheostomy and who are able to participate in inspiratory muscle training (IMT). Patients perform breathing exercises against a resistance device while researchers record the IMT dose, diaphragm function, ventilator duration, and hospital outcomes. The study correlates different IMT intensities and schedules with measures of respiratory muscle strength and time to wean from ventilation. The goal is to identify which IMT dosing patterns are associated with the best clinical recovery metrics.
Why it matters
Potential benefit: If successful, it could help shorten time on the ventilator and reduce ICU and hospital stays by improving diaphragm strength.
How similar studies have gone: Previous trials of general breathing exercises have not reliably shortened ventilator time, but smaller studies of inspiratory muscle training show promise for strengthening the diaphragm though the optimal dose remains unestablished.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mechanically ventilated patients with a tracheostomy * Aged ≥ 18 years * Co-operative and able to participate in IMT. * Informed consent or surrogate approval Exclusion Criteria: * 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.
Where it's running
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Royal Brompton and Harefield Hospitals
Marlow, United Kingdom Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.