Standardization of Inspiratory Muscle Training Dose in Mechanically Ventilated Patients: A Randomized Clinical Trial Using the Total Inspiratory Work Unit (UTIT).
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Maximal Inspiratory Pressure (Pimax)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Ability to cooperate with instructions or absence of deep sedation.
排除标准
- •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
研究组 & 干预措施
Low Dose Group (1,000 UTIT)
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
干预措施: Inspiratory Muscle Training (IMT) (Procedure)
Intermediate Dose Group (2,000 UTIT)
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.
干预措施: Inspiratory Muscle Training (IMT) (Procedure)
High Dose Group (3,000 UTIT)
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.
干预措施: Inspiratory Muscle Training (IMT) (Procedure)
结局指标
主要结局
Change in Maximal Inspiratory Pressure (Pimax)
时间窗: 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
时间窗: 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.
次要结局
- 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).)
研究者
Jose J Zaragoza, MD MSc
Principal Investigator
Hospital H+ Queretaro