Standardization of IMT Dosage (UTIT) in Mechanical Ventilation. (NCT07761468) | Clinical Trial Compass
By InvitationNot Applicable
Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.
Mexico60 participantsStarted 2025-08-01
Plain-language summary
Respiratory muscle weakness prolongs mechanical ventilation (MV) and delays weaning. Currently, there is no standardized dosage for Inspiratory Muscle Training (IMT) in the ICU. This study aims to define an optimal IMT dosage using a new metric called "Total Inspiratory Work Unit" (UTIT), which integrates intensity, repetition, and frequency.
The study compares three daily dosage regimens (1,000 UTIT, 2,000 UTIT, and 3,000 UTIT) adjusted daily based on the patient's Negative Inspiratory Force (NIF). The goal is to determine the optimal dose-response relationship for improving inspiratory muscle strength (PiMax) and reducing the duration of mechanical ventilation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (\>18 years of age) admitted to the Intensive Care Unit (ICU).
* Invasive mechanical ventilation support for more than 48-72 hours.
* Hemodynamic stability (defined as absence of vasopressors or receiving stable doses).
* Adequate oxygenation and ventilatory parameters: PEEP \< 10 cmH2O, FiO2 \< 0.6, and PaO2/FiO2 ratio \> 150-200.
* Ability to cooperate with instructions or absence of deep sedation.
Exclusion Criteria:
* Pre-existing neuromuscular pathology directly affecting respiratory muscles.
* Severe thoracic trauma or recent thoracic surgery.
* Unresolved pneumothorax or bronchopleural fistula.
* Severe hemodynamic instability or severe cardiac arrhythmias.
* Level of sedation that prevents active participation in sessions.
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Maximal Inspiratory Pressure (Pimax)
Timeframe: From baseline (study entry) up to successful weaning, extubation, or ICU discharge (up to 30 days).
2
Total Duration of Mechanical Ventilation
Timeframe: From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)