Skip to content

Identifying the Optimal IMT Dose in ICU

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07256821
Enrollment
40
Registered
2025-12-01
Start date
2025-11-23
Completion date
2027-01-31
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy

Brief 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

Interventions

OTHERInspiratory Muscle Training

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

Sponsors

Royal Brompton & Harefield NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic muscle activation (measured by electromyography)Up to 7 daysAt rest and at each IMT load on each study occasion
Extra diaphragmatic muscle activity (surface electromyography of scalene, sternocleidomastoid and parasternal muscles)Up to 7 daysAt rest and at each IMT load on each study occasion
Perceived difficultly and unpleasantness (number rating scale 0-10)Up to 7 daysAt 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)Up to 7 daysAt each IMT load on each study occasion

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026