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Enrolling by invitation

NCT Number: NCT07761468

Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.

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.

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Key information

Conditions

Ventilator Induced Diaphragm Dysfunction Mechanical Ventilation Weaning Respiratory Muscle Weakness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

Querétaro City, Querétaro, 76000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training (IMT)

Procedure

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital H+ Queretaro

Other

Registry information

Official study title

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

Acronym: UTIT-IMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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