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临床试验/NCT06684392
NCT06684392招募中不适用

Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation

Hospital Dr. Franco Ravera Zunino1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
56
试验地点
1
主要终点
Maximal inspiratory pressure

研究概览

简要总结

The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.

详细描述

Mechanical ventilation is a life-support intervention crucial for saving lives in ICU patients. However, its prolonged use leads to deterioration in respiratory muscle strength and endurance, causing diaphragm dysfunction. This weakening is associated with prolonged mechanical ventilation and increased difficulty in weaning the patient from the ventilator, known as "difficult weaning." It has been reported that up to 20% of ICU patients require tracheostomy due to this issue. Tracheostomy is an invasive procedure that involves creating an ostomy in the trachea to establish an artificial airway, allowing for ventilation, facilitating weaning from mechanical ventilation, and improving secretion management. However, muscle dysfunction from disuse and lack of effective respiratory muscle training extends the tracheostomy duration, leading to hospital-acquired infections, swallowing disorders, and increased ICU and hospital days. Thus, respiratory muscle training is a key tool for enabling tracheostomy removal (decannulation) and improving respiratory system efficiency. Since no universally accepted training protocol exists, it is not a common practice in ICUs worldwide, including our country. This project proposes that applying an individualized inspiratory muscle training regimen combining strength and endurance exercises for two weeks could improve respiratory muscle performance, reducing decannulation time (days from tracheostomy placement to removal).

The objective of this project is to assess the effect of an individualized inspiratory muscle training regimen, combining strength and endurance exercises for two weeks, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be evaluated: an experimental group undergoing individualized inspiratory muscle training for 14 days plus standard physiotherapy, and a control group receiving standard physiotherapy and weaning guided by scheduled mechanical ventilation disconnection windows. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The study results will optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and patients and improving their quality of life, thus aiding in meeting some health objectives for the 2011-2020 decade.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill patients aged ≥ 18 years
  • Connected to mechanical ventilation
  • Secondary tracheostomy due to prolonged mechanical ventilation
  • Glasgow Coma Scale (GCS) > 11 points
  • Level of cooperation score (S5Q) > 3 points

排除标准

  • Limitation of therapeutic effort (LTE*)
  • Pregnancy
  • Transfer to another center before completing the training (2 weeks)
  • Degenerative neuromuscular disease
  • Refusal to participate in this study (declining to provide informed consent [IC]).

结局指标

主要结局

Maximal inspiratory pressure

时间窗: 2 weeks

Maximum inspiratory pressure will be measured with the PowerBreathe valve before and after the training protocol to determine changes in diaphragm strength

次要结局

  • Diaphragm thickness(2 weeks)
  • Diaphragm excursion(2 weeks)

研究者

发起方
Hospital Dr. Franco Ravera Zunino
申办方类型
Other
责任方
Sponsor

研究点 (1)

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