Educational Programme in Diaphragm Ultrasonographic Assessment

NCT03704129 | Completed

• 1 other identifier: US Diaphragm Learning
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Educational Problems; Respiratory Muscle; Diaphragm Disease

Keywords

Diaphragm Ultrasound; Educational Programme

Outcome Measures

Primary Outcomes (2)

• Ultrasonographic skills - Thickening Fraction

  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

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

• Ultrasonographic skills - Diaphragm Displacement

  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.

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

Study Arms (2)

"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.

Other: Tutor

"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.

Interventions

Tutor OTHER

The participants 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.

"Tutor" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• students with no experience in the field of ultrasound

You may not qualify if:

• None

Sponsors & Collaborators

• Paolo Navalesi: lead

Study Sites (1)

Eugenio Garofalo

Catanzaro, CZ, 88100, Italy

Location

Related Publications (4)

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.

  PMID: 27620292 BACKGROUND

• Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.

  PMID: 25886857 BACKGROUND

• Garofalo E, Bruni A, Pelaia C, Landoni G, Zangrillo A, Antonelli M, Conti G, Biasucci DG, Mercurio G, Cortegiani A, Giarratano A, Vetrugno L, Bove T, Forfori F, Corradi F, Vaschetto R, Cammarota G, Astuto M, Murabito P, Bellini V, Zambon M, Longhini F, Navalesi P, Bignami E. Comparisons of two diaphragm ultrasound-teaching programs: a multicenter randomized controlled educational study. Ultrasound J. 2019 Oct 3;11(1):21. doi: 10.1186/s13089-019-0137-4.

  PMID: 31578700 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: October 12, 2018
• Study Start: December 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the anticipated end of the trial
• Access Criteria: Motivated request by e-mailing

Locations

IT (1)