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.
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
- Are there results?
- Not yet: the study is under way
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
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).
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Inspiratory Muscle Training Dose in Mechanically Ventilated Patients: A Randomized Clinical Trial Using the Total Inspiratory Work Unit (UTIT).
- ClinicalTrials.gov ID
- NCT07761468
- Acronym / sponsor ID
- UTIT-IMT / CEI2025-12V1
- Conditions
- Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness, Mechanical Ventilation Weaning
- Keywords
- Inspiratory Muscle Training, Intensive Care Unit, Total Inspiratory Work Unit (TIWU), Negative Inspiratory Force (NIF), Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment.
| Arm | Type | Receives |
|---|---|---|
| Low Dose Group (1,000 UTIT) | Experimental | Procedure: Inspiratory Muscle Training (IMT)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 |
| Intermediate Dose Group (2,000 UTIT) | Experimental | Procedure: Inspiratory Muscle Training (IMT)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. |
| High Dose Group (3,000 UTIT) | Experimental | Procedure: Inspiratory Muscle Training (IMT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training (IMT)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). | Procedure or surgery | High Dose Group (3,000 UTIT), Intermediate Dose Group (2,000 UTIT), Low Dose Group (1,000 UTIT) |
Primary outcome
Change in Maximal Inspiratory Pressure (Pimax)
Time frame: From baseline (study entry) up to successful weaning, extubation, or ICU discharge (up to 30 days).
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.
Total Duration of Mechanical Ventilation
Time frame: From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)
Total number of consecutive days a patient requires invasive mechanical ventilation support via endotracheal tube.
3 secondary outcomes
Duration of the Weaning Process
Time frame: From the start of the weaning process up to successful extubation (up to 30 days)
Reintubation Rate Within 72 Hours
Time frame: Within 72 hours post-extubation
Length of Stay in Intensive Care Unit (ICU)
Time frame: From study enrollment until ICU discharge (up to 30 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Inspiratory Pressure (Pimax) (time frame: From baseline (study entry) up to successful weaning, extubation, or ICU discharge (up to 30 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.