Identifying the Optimal IMT Dose in ICU

NCT ID: NCT07256821

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-23
• Study Completion Date: 2027-01-31

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

Conditions

Difficult to Wean, Mechanically Ventilated Patients With a Tracheostomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Inspiratory Muscle Training

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Brompton and Harefield Hospitals

Marlow, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Timothy Jenkins

Role: primary

timothy.jenkins4@nhs.net

020 7352 8121

Other Identifiers

25/WA/0242

Identifier Type: -

Identifier Source: org_study_id