Ventilator Induced Diaphragm DysfunctionUTIT-IMTNCT07761468

Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.

A study testing Inspiratory Muscle Training (IMT) in people with Ventilator Induced Diaphragm Dysfunction and Respiratory Muscle Weakness, run by Hospital H+ Queretaro at 1 site in Mexico.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness, Mechanical Ventilation Weaning
What is being tested?: Inspiratory Muscle Training (IMT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteMexico
Study dates: 1 Aug 2025to 1 Nov 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site

Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
Querétaro City, Querétaro, 76000

Other trials in Mexico

About this study

Official title: Standardization of Inspiratory Muscle Training Dose in Mechanically Ventilated Patients: A Randomized Clinical Trial Using the Total Inspiratory Work Unit (UTIT).

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.

Read the detailed description

This is a randomized clinical trial conducted at Hospital H+ Querétaro. Eligible intubated patients will be assigned to one of three intervention groups differing in the daily volume of inspiratory work.

The "Total Inspiratory Work Unit" (UTIT) is defined as: UTIT = (Target NIF %) x (Number of Breaths per Session) x (Number of Sessions per Day).

Intensity is adjusted daily to maintain the target UTIT dose. The study utilizes a threshold loading device (POWERbreathe K5) with real-time feedback. Safety parameters (SpO2, HR, FR, MAP) are monitored continuously during sessions. The intervention continues until successful weaning, extubation, ICU discharge, or death.

Conditions: Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness, Mechanical Ventilation Weaning
Being tested: Inspiratory Muscle Training (IMT)
Keywords: Inspiratory Muscle Training, Intensive Care Unit, Total Inspiratory Work Unit (TIWU), Negative Inspiratory Force (NIF), Mechanical Ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inspiratory Muscle Training (IMT)Procedure or surgery
Respiratory rehabilitation training using a specific threshold loading device (POWERbreathe K5) with real-time feedback. The intervention aims to strengthen inspiratory muscles (diaphragm and intercostals). The daily dosage is calculated using the Total Inspiratory Work Unit (UTIT) formula, adjusted daily based on the patient's Negative Inspiratory Force (NIF).

Study groups in NCT07761468
Study group	Role	What they receive
Low Dose Group (1,000 UTIT)	Experimental	Participants receive a daily IMT dosage of 1,000 Total Inspiratory Work Units (UTIT). Intensity: 30% of the patient's baseline Negative Inspiratory Force (NIF). Repetitions: 30 breaths per session. Frequency: 1 session per day Receives: Procedure: Inspiratory Muscle Training (IMT)
Intermediate Dose Group (2,000 UTIT)	Experimental	Participants receive a daily IMT dosage of 2,000 Total Inspiratory Work Units (UTIT). Intensity: 50% of the patient's baseline Negative Inspiratory Force (NIF). Repetitions: 60 breaths per session. Frequency: 2 sessions per day. Receives: Procedure: Inspiratory Muscle Training (IMT)
High Dose Group (3,000 UTIT)	Experimental	Participants receive a daily IMT dosage of 3,000 Total Inspiratory Work Units (UTIT). Intensity: 80% of the patient's baseline Negative Inspiratory Force (NIF). Repetitions: 60 breaths per session. Frequency: 3 sessions per day. Receives: Procedure: Inspiratory Muscle Training (IMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Maximal Inspiratory Pressure (Pimax)
Change in maximal inspiratory pressure measured in cmH₂O using the POWERbreathe K5 device to evaluate inspiratory muscle strength from baseline to the end of the intervention.
Measured: From baseline (study entry) up to successful weaning, extubation, or ICU discharge (up to 30 days).
Total Duration of Mechanical Ventilation
Total number of consecutive days a patient requires invasive mechanical ventilation support via endotracheal tube.
Measured: From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)

Secondary outcomes (3)

Duration of the Weaning Process
Number of days from the first spontaneous breathing trial (SBT) or initiation of weaning protocol until successful extubation
Measured: From the start of the weaning process up to successful extubation (up to 30 days)
Reintubation Rate Within 72 Hours
Percentage of patients who require reintubation within 72 hours following initial planned extubation.
Measured: Within 72 hours post-extubation
Length of Stay in Intensive Care Unit (ICU)
Total number of days the patient remains admitted to the ICU.
Measured: From study enrollment until ICU discharge (up to 30 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20251 Nov 2026

First posted12 Aug 2026
Study start1 Aug 2025
Primary completion30 Aug 2026 (estimated)
Study completion1 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ventilator Induced Diaphragm DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment.
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07761468
Sponsor's protocol ID: CEI2025-12V1
Other IDs: REHAB-25-1
Acronym: UTIT-IMT
Status last verified: Aug 2026
First submitted: 3 Aug 2026
Last updated: 12 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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