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Standardization of IMT Dosage (UTIT) in Mechanical Ventilation. (UTIT-IMT)

2026年8月10日 更新者：Jose J Zaragoza, MD MSc、Hospital H+ Queretaro

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

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.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 墨西哥
    • Querétaro
      • Querétaro City、Querétaro、墨西哥、76000
        • Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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
程序：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).
实验性的：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.
程序：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).
实验性的：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.
程序：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Maximal Inspiratory Pressure (Pimax)
大体时间：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.
From baseline (study entry) up to successful weaning, extubation, or ICU discharge (up to 30 days).
Total Duration of Mechanical Ventilation
大体时间：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.
From the initiation of mechanical ventilation until successful extubation or ICU discharge (up to 30 days)

次要结果测量

结果测量
措施说明
大体时间
Duration of the Weaning Process
大体时间：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
From the start of the weaning process up to successful extubation (up to 30 days)
Reintubation Rate Within 72 Hours
大体时间：Within 72 hours post-extubation
Percentage of patients who require reintubation within 72 hours following initial planned extubation.
Within 72 hours post-extubation
Length of Stay in Intensive Care Unit (ICU)
大体时间：From study enrollment until ICU discharge (up to 30 days).
Total number of days the patient remains admitted to the ICU.
From study enrollment until ICU discharge (up to 30 days).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospital H+ Queretaro

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月1日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CEI2025-12V1
  • REHAB-25-1 (其他标识符：CEI2025-12V1)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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