Mechanical Ventilation Weaning, Respiratory Muscle Weakness, Ventilator Induced Diaphragm Dysfunction
Conditions
Keywords
Inspiratory Muscle Training, Intensive Care Unit, Total Inspiratory Work Unit (TIWU), Negative Inspiratory Force (NIF), Mechanical Ventilation
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.
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.
Interventions
PROCEDUREInspiratory 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).
Sponsors
Hospital H+ Queretaro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the Weaning Process | 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 |
| Reintubation Rate Within 72 Hours | Within 72 hours post-extubation | Percentage of patients who require reintubation within 72 hours following initial planned extubation. |
| Length of Stay in Intensive Care Unit (ICU) | From study enrollment until ICU discharge (up to 30 days). | Total number of days the patient remains admitted to the ICU. |
Countries
Mexico
Outcome results
None listed