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临床试验/NCT07747532
NCT07747532尚未招募不适用

Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
58
试验地点
1
主要终点
To measure the intra-rater reliability of the excursion of the zone of apposition, (ZOA)

研究概览

简要总结

It is often difficult for anesthesiologists to select an ultrasound method that will give consistent results and also be a reliable way to examine the diaphragm, especially on the left side of the chest.

In this study, two anesthesiologists blinded to one another's scan results, will perform ultrasound scan of the diaphragm using three different methods and the measurements will be analyzed to see the reliability of each method.

详细描述

Ultrasound assessment of the diaphragm is a portable and non-invasive option for assessing and monitoring diaphragmatic function. The diaphragm is the main muscle used for breathing. It is a muscular organ that lies in between the thorax (chest) and abdomen. By moving up and down, it helps in our breathing by aiding both the right and the left lung to inflate and deflate. Assessing diaphragmatic function provides meaningful information in the setting of chronic lung diseases, obesity and diseases of nerve and muscle dysfunction and in assessing the diaphragmatic function before and after surgery. However, ultrasound assessment of the diaphragm on the left side of chest is sometimes difficult or impossible in a large proportion of patients.

There are currently three ultrasound methods to examine the diaphragm, and to date, it is not clear which technique should be used as the most reliable method. The purpose of this research study is to find out how much reliable the different ultrasound methods are in assessing the movement of the diaphragm during respiration.

In this study, two anesthesiologists blinded to one another's scan results, will perform ultrasound scan of the diaphragm using three different methods and the measurements will be analyzed to see the reliability of each method. The investigators believe that the results of this study can guide medical professionals in selecting an ultrasound method that will give consistent results and a more reliable way to examine the diaphragm, especially on the left side of the chest.

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

  • Participants must meet all the following inclusion criteria to be eligible for the study:
  • Any elective surgical patient
  • Age ≥18 years
  • American Society of Anesthesiologists class I to III

排除标准

  • Participants will not be eligible for the study if any of the exclusion criteria is present:
  • Pregnancy - patients will be asked if they are pregnant or not and screened post-consent from their medical chart.
  • History of diaphragmatic dysfunction
  • Previous surgical procedures on the lung, thorax or diaphragm.
  • Inability to understand the study activities and provide informed consent when explained about the study and the consent process
  • Refusal to participate in study

结局指标

主要结局

To measure the intra-rater reliability of the excursion of the zone of apposition, (ZOA)

时间窗: Through study completion, an average of 2 years

To measure the intra-rater (between two measurements of the same scanner) reliability of the excursion of the ZOA using a linear probe over the lateral chest wall, quantified by Intraclass correlation coefficients (ICC).

To measure the inter-rater reliability of the excursion of the zone of apposition, (ZOA)

时间窗: Through study completion, an average of 2 years

To measure the inter-rater (between two ultrasound scanners) reliability of the excursion of the zone of apposition, (ZOA) using a linear probe over the lateral chest wall, quantified by Intraclass correlation coefficients (ICC).

次要结局

  • To measure the intra-rater reliability of the excursion of the dome of the diaphragm (DOD)(Through study completion, an average of 2 years)
  • To measure the inter-rater reliability of the excursion of the dome of the diaphragm (DOD)(Through study completion, an average of 2 years)
  • To measure intra-rater reliability of the Thickening Fraction, (TF) of the ZOA(Through study completion, an average of 2 years)
  • To measure inter-rater reliability of the Thickening Fraction, (TF) of the ZOA(Through study completion, an average of 2 years)
  • To measure the distribution of diaphragmatic measurements obtained for the ZOA method (Excursion of the ZOA)(Through study completion, an average of 2 years)
  • To measure the distribution of diaphragmatic measurements obtained for the DOD method(Through study completion, an average of 2 years)
  • To measure the distribution of diaphragmatic measurements obtained for the Thickening Fraction method (TF of the ZOA)(Through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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