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RecruitingNCT07256821Updated Jan 12, 2026

Identifying the Optimal IMT Dose in ICU

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

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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.

  1. 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.
  2. 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

02

Conditions studied

  • Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Difficult to wean, mechanically ventilated patients

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • OtherInspiratory Muscle Training

    Inspiratory muscle training at no load, and at 15, 25, 35 and 45% participants maximal inspiratory pressure

06

What researchers measure

Primary outcomes

  1. Diaphragmatic muscle activation (measured by electromyography)

    At rest and at each IMT load on each study occasion

    Time frame: Up to 7 days

  2. 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

  3. Perceived difficultly and unpleasantness (number rating scale 0-10)

    At each IMT load on each study occasion

    Time frame: Up to 7 days

  4. 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

07

Study locations

1 of 1 sites recruiting
  • Royal Brompton and Harefield Hospitals
    Marlow, SL7 3AS, United Kingdom
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07256821
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
Responsible party
Sponsor
First posted
Dec 1, 2025
Start date
Nov 23, 2025
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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