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临床试验/NCT03704129
NCT03704129已完成不适用

Evaluation of a 2-hour Educational Programme in Diaphragm Ultrasonographic Assessment

Paolo Navalesi2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2018年12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
已完成
发起方
入组人数
172
试验地点
2
主要终点
Ultrasonographic skills - Diaphragm Displacement

研究概览

简要总结

Diaphragm ultrasound non-invasively explores the diaphragm function and it can be useful in several clinical situations. Diaphragm ultrasound is able to evaluate the cranio-caudal displacement of the diaphragm and its thickening fraction at the end of inspiration, in relation to the end-expiratory value.

While several studies have been conducted in the evaluation of educational programmes for echocardiography, to date data lack regarding this aspect in diaphragm ultrasonographic assessment.

Based on the experience gained in some specialization schools in Anaesthesia and Intensive Care, the investigators hypothesize that the participation in a two-hour course, including a theoretical part and a practical training, allows to acquire the appropriate theoretical and practical skills necessary to correctly perform the measurement of the diaphragm excursion and thickening fraction, compared to the theoretical lesson only, followed by a brief explanation by an expert tutor, on the practical use of the ultrasound.

The investigators hypothesized that the association of the theoretical part and of the practical training is able to obtain:

  1. Passing the theoretical test with at least 70% of the correct answers;
  2. The correct identification of the areas where the probe is affixed;
  3. The appropriate measure of Diaphragmatic thickening and displacement.

详细描述

  1. INTRODUCTION Diaphragm ultrasound non-invasively explores the diaphragm function and it can be useful in several clinical situations. Diaphragm ultrasound is able to evaluate the cranio-caudal displacement of the diaphragm and its thickening fraction at the end of inspiration, in relation to the end-expiratory value. These parameters provide useful data in the evaluation and management of patients affected by diaphragm dysfunction; moreover, they are gaining an increasing role in the evaluation of patients undergoing mechanical ventilation.

To assess the diaphragm activity, clinicians use two different sonographic windows:

i. to evaluate diaphragmatic thickness in the zone of apposition of the diaphragm to the rib cage. Physicians can assess thickening fraction between the 8th and 10th intercostal space, on the anterior or midaxillary line, 0.5-2 cm below the costophfrenic angle. The zone of apposition is the area of the chest wall where the abdominal contents reach the lower rib cage. In this area, the diaphragm is observed as a structure made of three distinct layers: a non-echogenic central layer bordered by two echogenic layers, the peritoneum and the diaphragmatic pleurae. To obtain adequate images of diaphragmatic thickness in M mode and 2D mode, a linear high-frequency probe (≥10 MHz) is necessary. The diaphragmatic thickness can be measured during quiet spontaneous breathing and during a maximal inspiratory and expiratory effort. An index of diaphragmatic thickening, the thickening fraction (TF) can be calculated using the M mode (TF = thickness at endinspiration - thickness at end-expiration/thickness at end-expiration). Diaphragmatic thickening fraction can be used as an index of diaphragmatic efficiency as a pressure generator. In normal individuals, there is a wide range of tdi at functional residual capacity (FRC), ranging between 1.8 to 3 mm. As lung volume increases from the residual volume (RV) to total lung capacity (TLC) there is a mean tdi increase of 54 % (range 42-78 %). Furthermore, the diaphragm also thickens during a maximal inspiratory pressure (Pimax) maneuver at FRC. A thickening ratio of 2.6 can be measured, dividing the diaphragmatic thickness during Pimax at FRC by the diaphragmatic thickness while relaxing at FRC.

ii. the physicians can also assess the diaphragmatic displacement (or excursion) trough a 3.5-5 mHz phased array probe. The probe is placed immediately below the right costal margin in the mid-clavicular line or in the right anterior axillary line, and it is directed medially, cephalad and dorsally, in order that the ultrasound beam perpendicularly reached the hemi-diaphragm in its posterior third portion. After obtaining the best approach in two-dimensional mode, the displacement was measured in M-mode displaying the motion of the hemi-diaphragm along the selected line. In healthy subjects during spontaneous breathing, the inspiratory diaphragm excursion is 1.34 ± 0.18 cm.

In patients undergoing assist mechanical ventilation, the thickening fraction is an indicator of inspiratory effort. While several studies have been conducted in the evaluation of educational programmes for echocardiography, to date data regarding this aspect in diaphragm ultrasonographic assessment lack. 2. AIM OF THE STUDY

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • 116 students with no experience in the field of ultrasound

排除标准

  • 未提供

研究组 & 干预措施

"Tutor" group

Experimental

After a theoretical part through the administration of a video-tutorial, a 10-point questionnaire will be administered to evaluate the level of learning for each participant. Every single participant will pass the test if he/she correctly answer to >70% of the questions. Those passing the test, will be randomized to two groups.

The interventional group will access the practical training, during which each participant will be followed by a tutor who will interactively explain, using a healthy volunteer, how to perform the ultrasound scan of the diaphragm. The ultrasound will be performed on a healthy volunteer first by the tutor and then by the participants. During the exercise, each individual learner will be supervised by the tutor himself.

干预措施: Tutor (Other)

"No tutor" group

No Intervention

This control group will directly perform the ultrasound examination of the diaphragm. The expert tutor will only show the learners how to use the various functions of the ultrasound, the linear and convex probes both in two-dimensional and in M-mode.

结局指标

主要结局

Ultrasonographic skills - Diaphragm Displacement

时间窗: Soon after the video-tutorial (within 30 minutes), when participants perform diaphragm ultrasound

Measurement of Diaphragm Displacement. If students' measurements will deviate from those recorded by the expert within the +/- 2 mm, the result will be considered positive.

Ultrasonographic skills - Thickening Fraction

时间窗: Soon after the video-tutorial (within 30 minutes), when participants perform diaphragm ultrasound

Measurement of thickening fraction. If measurements will deviate from those recorded by the expert within the 20% of the value, the result will be considered positive

次要结局

未报告次要终点

研究者

发起方
Paolo Navalesi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paolo Navalesi

Prof

University Magna Graecia

研究点 (2)

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