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Набор скоро начнётся NCT07747532

Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis

Наблюдательное Diaphragm Issues

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Diaphragm Issues. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • To measure the intra-rater reliability of the excursion of the zone of apposition, (ZOA) [Срок оценки: Through study completion, an average of 2 years]
  • To measure the inter-rater reliability of the excursion of the zone of apposition, (ZOA) [Срок оценки: Through study completion, an average of 2 years]
Вторичные конечные точки (7)
  • To measure the intra-rater reliability of the excursion of the dome of the diaphragm (DOD) [Срок оценки: Through study completion, an average of 2 years]
  • To measure the inter-rater reliability of the excursion of the dome of the diaphragm (DOD) [Срок оценки: Through study completion, an average of 2 years]
  • To measure intra-rater reliability of the Thickening Fraction, (TF) of the ZOA [Срок оценки: Through study completion, an average of 2 years]
  • To measure inter-rater reliability of the Thickening Fraction, (TF) of the ZOA [Срок оценки: Through study completion, an average of 2 years]
  • To measure the distribution of diaphragmatic measurements obtained for the ZOA method (Excursion of the ZOA) [Срок оценки: Through study completion, an average of 2 years]
  • To measure the distribution of diaphragmatic measurements obtained for the DOD method [Срок оценки: 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) [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Toronto Western Hospital, University Health Network — Toronto

Идентификаторы

NCT: NCT07747532 · 26-5084

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗