An interventional study of Inspiratory Muscle Training (IMT) in Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness and Mechanical Ventilation Weaning, sponsored by Hospital H+ Queretaro. Enrolling by invitation at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Hospital H+ Queretaro · Not applicable, Interventional, and Treatment
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.
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.
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 362 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Hospital H+ Queretaro is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Procedure: 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).
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.
Time frame: 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.
Time frame: From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)
Duration of the Weaning Process
Number of days from the first spontaneous breathing trial (SBT) or initiation of weaning protocol until successful extubation
Time frame: 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.
Time frame: Within 72 hours post-extubation
Length of Stay in Intensive Care Unit (ICU)
Total number of days the patient remains admitted to the ICU.
Time frame: From study enrollment until ICU discharge (up to 30 days).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hospital H+ Queretaro