跳至主要内容
临床试验/NCT07538102
NCT07538102招募中不适用

Effect of Respiratory Physiotherapy on Diaphragmatic Thickness in Mechanically Ventilated Patients in Intensive Care Unit: A Prospective Observational Controlled Trial

Hitit University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
Change in Diaphragm Thickness

研究概览

简要总结

This study aims to evaluate the effect of respiratory physiotherapy on diaphragm thickness in patients receiving mechanical ventilation support in the intensive care unit. Thinning and dysfunction of the diaphragm muscle observed during mechanical ventilation complicate the extubation process and increase the risk of respiratory failure in patients. Diaphragm dysfunction prolongs ventilator use and increases ICU mortality. The main objective of this research is to determine whether respiratory physiotherapy has protective or ameliorative effects on diaphragm muscle structure and function, to optimize the ventilator weaning process, and to provide scientific contributions to the field of respiratory rehabilitation. Changes in diaphragm thickness will be objectively evaluated using ultrasonography, and the aim is to obtain evidence-based data on the effectiveness of respiratory physiotherapy.

详细描述

Mechanical ventilation (MV) is a widely used basic life support method to provide respiratory support to individuals with life-threatening illnesses in intensive care units. However, long-term MV application and inability to wean from the ventilator are considered two of the most important risk factors increasing morbidity and mortality rates in intensive care patients. In addition, this situation creates a serious economic burden for the healthcare system. Despite the life-saving effects of MV, complications such as ventilator-associated pneumonia, atelectasis, barotrauma/volutrauma, patient-ventilator asynchrony, and pulmonary embolism can develop during the application process. Furthermore, the weaning process from mechanical ventilation is critical for enabling the patient to transition to spontaneous breathing and requires the fulfillment of objective criteria such as arterial pH, oxygenation, metabolic stability, and elimination of the underlying cause . The diaphragm, the primary muscle of the respiratory system, plays a decisive role in the successful termination of mechanical ventilation. Prolonged mechanical ventilation (MV) support leads to decreased diaphragm activity due to insufficient or excessive ventilator pressure, patient-ventilator mismatch, critical illness polyneuropathy, and systemic infections, resulting in diaphragm atrophy and dysfunction. This condition is defined as ventilator-associated diaphragm dysfunction (VIDD) and leads to prolonged MV duration, extubation failure, and increased mortality. The literature shows that VIDD is one of the most important determinants of long-term MV dependence and negatively affects clinical outcomes .

In recent years, ultrasonography (USG), a non-invasive, reliable, and reproducible method for evaluating diaphragm function, has come to the forefront. Measuring diaphragm thickness with USG provides valuable information both for the detection of VIDD and for planning the timing of extubation. In addition, early mobilization and respiratory physiotherapy applications have been shown to be effective in increasing consciousness levels, reducing complications, and shortening MV duration and ICU stay in intensive care patients . However, the effect of early respiratory physiotherapy on diaphragm structure and function has not yet been sufficiently investigated. Therefore, this study aims to evaluate the effect of respiratory physiotherapy on diaphragm thickness in intensive care patients with objective data and to determine whether it contributes to the prevention of VIDD development.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years
  • Mechanically ventilated for at least 5 days
  • Hemodynamically stable
  • Unconscious (Glasgow Coma Scale indicating impaired consciousness)
  • Informed consent obtained from legal representatives

排除标准

  • Neuromuscular disease
  • Traumatic diaphragm injury
  • Thoracic deformity causing mechanical impairment of respiration
  • Terminal-stage patients
  • Patients in whom respiratory physiotherapy is contraindicated
  • Presence of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD)

研究组 & 干预措施

Group A

Standard ICU physiotherapy will be applied once daily for 15-20 minutes.

干预措施: Standard ICU Physiotherapy (Other)

Group B

In addition to standard ICU physiotherapy once daily for 15-20 minutes, neuromuscular electrical stimulation (NMES) will be applied to the diaphragmatic region twice daily.

干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)

结局指标

主要结局

Change in Diaphragm Thickness

时间窗: Baseline (start of mechanical ventilation), Day 5, Day 7, or discharge day (whichever comes first)

Diaphragm thickness measured by ultrasonography (high-frequency linear probe, 5-15 MHz) at the right midaxillary line between the 8th and 9th ribs in the transverse plane, at end-inspiration and end-expiration. Diaphragm Thickening Fraction (DTF) calculated as: DTF (%) = \[(Inspiratory Thickness - Expiratory Thickness) / Expiratory Thickness\] × 100

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Talha KIRATLI

Principal Investigator

Hitit University

研究点 (1)

Loading locations...

相似试验