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Clinical Trials in Mexico / NCT07761468
Enrolling by invitation Not applicable

Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.

NCT07761468 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital H+ Queretaro
Phase
Not applicable
Started
2025-08-01
Last updated
2026-08-12

Condition(s) studied

Ventilator Induced Diaphragm DysfunctionRespiratory Muscle WeaknessMechanical Ventilation Weaning

Investigational drug(s) / intervention(s)

Inspiratory Muscle Training (IMT)

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Maximal Inspiratory Pressure (Pimax) — 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 — 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.

Trial sites (1)

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

More Hospital H+ Queretaro trials in Mexico

Fecal Lactate and Resuscitation Outcomes in Critical Illness Active, not recruiting
Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07761468 on ClinicalTrials.gov ↗ ← All trials in Mexico