Standardization of IMT Dosage (UTIT) in Mechanical Ventilation. (UTIT-IMT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Querétaro
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Querétaro City, Querétaro, Mexico, 76000
- Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Dose Group (1,000 UTIT)
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 |
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).
|
|
Experimental: Intermediate Dose Group (2,000 UTIT)
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. |
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).
|
|
Experimental: High Dose Group (3,000 UTIT)
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. |
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline (study entry) up to successful weaning, extubation, or ICU discharge (up to 30 days).
|
|
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.
|
From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of the Weaning Process
Time Frame: From the start of the weaning process up to successful extubation (up to 30 days)
|
Number of days from the first spontaneous breathing trial (SBT) or initiation of weaning protocol until successful extubation
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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
|
Percentage of patients who require reintubation within 72 hours following initial planned extubation.
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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).
|
Total number of days the patient remains admitted to the ICU.
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From study enrollment until ICU discharge (up to 30 days).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CEI2025-12V1
- REHAB-25-1 (Other Identifier: CEI2025-12V1)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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