Identifying the Optimal IMT Dose in ICU

NCT07256821 | Recruiting DMC

• 1 other identifier: 25/WA/0242
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.After each breathing exercise level patients will be asked how they found it - for example, easy, pleasant, scary.

Conditions

Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy

Outcome Measures

Primary Outcomes (4)

• Diaphragmatic muscle activation (measured by electromyography)

  At rest and at each IMT load on each study occasion

  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

  Up to 7 days

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

  At each IMT load on each study occasion

  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

  Up to 7 days

Interventions

Inspiratory Muscle Training OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Difficult to wean, mechanically ventilated patients

You may qualify if:

• Mechanically ventilated patients with a tracheostomy
• Aged ≥ 18 years
• Co-operative and able to participate in IMT.
• Informed consent or surrogate approval

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton and Harefield Hospitals

Marlow, SL7 3AS, United Kingdom

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 1, 2025
• Study Start: November 23, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)