Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.

NCT07761468 | Enrolling By Invitation

• 2 other identifiers: CEI2025-12V1REHAB-25-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)

Secondary Outcomes (3)

• Duration of the Weaning Process

  From the start of the weaning process up to successful extubation (up to 30 days)

• Reintubation Rate Within 72 Hours

  Within 72 hours post-extubation

• Length of Stay in Intensive Care Unit (ICU)

  From study enrollment until ICU discharge (up to 30 days).

Study Arms (3)

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

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.

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.

Procedure: Inspiratory Muscle Training (IMT)

Interventions

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).

High Dose Group (3,000 UTIT); Intermediate Dose Group (2,000 UTIT); Low Dose Group (1,000 UTIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

Study Sites (1)

Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

Querétaro City, Querétaro, 76000, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

ME (1)