Diaphragmatic Motion Using Linear Ultrasound

NCT03225508 | Completed

• 1 other identifier: 16-6385
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the movement of the diaphragm (which is the main muscle used for breathing). It will compare two ultrasound modalities: linear ultrasound versus curvilinear ultrasound, at measuring diaphragm motion. The proposed measurement method with linear ultrasound is novel, and will be compared against the established method with curvilinear ultrasound. The investigators hypothesize that the novel method will have several potential advantages, including: it may be easier to learn, quicker to perform, and have a lower failure rate.

Conditions

Diaphragm; Movement; Examination of Diaphragm Movement Using Ultrasound

Outcome Measures

Primary Outcomes (1)

• Time taken to measure diaphragmatic excursion

  To measure in minutes the time taken to quantify diaphragmatic excursion from end inspiration to end expiration, and to compare the linear probe versus the curvilinear probe.

  60 minutes

Secondary Outcomes (3)

• Normal range of values for diaphragmatic excursion using linear ultrasound

  30 mins

• Quantify and compare the reduction in diaphragmatic motion following a phrenic nerve block

  2 hours

• Success rate of measuring both the left and right hemi-diaphragmatic movement

  60 mins

Study Arms (2)

Phase 1

The first phase will be to evaluate a new lung ultrasound technique to measure diaphragmatic excursion using a linear probe in the mid-axillary line. This will involve scanning 75 healthy patients undergoing elective surgery to determine normal reference values in men and women. The following interventions will be carried out: (i) Measurement of diaphragmatic movement with a linear ultrasound probe on both sides of the chest (ii) Measurement of diaphragmatic movement with a curved ultrasound probe on both sides of the chest

Diagnostic Test: Linear Ultrasound to Measure Diaphragmatic Movement; Diagnostic Test: Curvilinear Ultrasound to Measure Diaphragmatic Movement

Phase 2

This will involve patients undergoing an interscalene / supraclavicular brachial plexus block for their routine care, it will examine the reduction in diaphragmatic motion due to phrenic nerve palsy. Interventions: (i) Measurement of diaphragmatic movement with a linear ultrasound probe bilaterally. (ii) Measurement of diaphragmatic movement with a curved ultrasound probe bilaterally. (iii) Pulmonary function tests prior to the brachial plexus block (iv) Planned supraclavicular / interscalene block by the clinical team. (v) Repeat measurement of diaphragmatic movement with linear ultrasound, only on the side of the brachial plexus block. (vi) Repeat measurement of diaphragmatic movement with curved ultrasound, only on the side of the brachial plexus block.

Diagnostic Test: Linear Ultrasound to Measure Diaphragmatic Movement; Diagnostic Test: Curvilinear Ultrasound to Measure Diaphragmatic Movement; Diagnostic Test: Pulmonary function tests

Interventions

Linear Ultrasound to Measure Diaphragmatic Movement DIAGNOSTIC_TEST

A linear 10-12 MHz ultrasound probe will be used to determine diaphragmatic excursion, by examining the zone of apposition. Diaphragmatic excursion will be measured from end inspiration to end expiration. The measurement will be repeated twice, and an average of the two will be taken. The distance between the two external skin markings, one at the end of full expiration and one at the end of full inspiration will indicate the excursion of the diaphragm.

Phase 1; Phase 2

Curvilinear Ultrasound to Measure Diaphragmatic Movement DIAGNOSTIC_TEST

A curvilinear 2-5 MHz ultrasound probe will be used to determine diaphragmatic excursion, by examining the dome of the diaphragm. M-mode will be used to image the motion of the diaphragm from end inspiration to end expiration. The measurement will be repeated twice, and an average of the two will be taken.

Phase 1; Phase 2

Pulmonary function tests DIAGNOSTIC_TEST

Bedside pulmonary function tests to measure forced vital capacity (FVC). The FVC measures the maximal volume of gas that can be expired as forcefully and rapidly as possible after a maximal inspiration to total lung capacity. This measurement will help determine if the patient has any obstructive or restrictive diseases of the airways. Three measurements will be taken.

Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Phase 1 Any healthy adult patient undergoing elective surgery Phase 2 Any adult patient, undergoing elective upper limb surgery that involves an interscalene or supraclavicular brachial plexus block.

You may qualify if:

• Phase 1 Any healthy adult patient undergoing elective surgery
• Phase 2 Any adult patient, undergoing elective upper limb surgery that involves an interscalene or supraclavicular brachial plexus block.

You may not qualify if:

• (i) Inability to obtain an informed consent (e.g. language barrier) (ii) BMI \> 35 (iii) Known pre-existing diaphragmatic dysfunction (iv) Existing lung pathology
• Smoker
• Known abnormal pulmonary function tests
• Severe pulmonary disease e.g., COPD, asthma, pulmonary fibrosis, or any other significant respiratory disease that would adversely affect diaphragm function or pulmonary function tests
• Additional Criteria for Phase 2 Any contraindication to an interscalene or supraclavicular brachial plexus block

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (20)

• Sferrazza Papa GF, Pellegrino GM, Di Marco F, Imeri G, Brochard L, Goligher E, Centanni S. A Review of the Ultrasound Assessment of Diaphragmatic Function in Clinical Practice. Respiration. 2016;91(5):403-11. doi: 10.1159/000446518. Epub 2016 May 25.

  PMID: 27216909 BACKGROUND

• Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

  PMID: 19017880 BACKGROUND

• Kim SH, Na S, Choi JS, Na SH, Shin S, Koh SO. An evaluation of diaphragmatic movement by M-mode sonography as a predictor of pulmonary dysfunction after upper abdominal surgery. Anesth Analg. 2010 May 1;110(5):1349-54. doi: 10.1213/ANE.0b013e3181d5e4d8.

  PMID: 20418298 BACKGROUND

• Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.

  PMID: 21705883 BACKGROUND

• Lerolle N, Guerot E, Dimassi S, Zegdi R, Faisy C, Fagon JY, Diehl JL. Ultrasonographic diagnostic criterion for severe diaphragmatic dysfunction after cardiac surgery. Chest. 2009 Feb;135(2):401-407. doi: 10.1378/chest.08-1531. Epub 2008 Aug 27.

  PMID: 18753469 BACKGROUND

• Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.

  PMID: 21144957 BACKGROUND

• Baldwin CE, Paratz JD, Bersten AD. Diaphragm and peripheral muscle thickness on ultrasound: intra-rater reliability and variability of a methodology using non-standard recumbent positions. Respirology. 2011 Oct;16(7):1136-43. doi: 10.1111/j.1440-1843.2011.02005.x.

  PMID: 21645172 BACKGROUND

• DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

  PMID: 24365607 BACKGROUND

• Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

  PMID: 24949192 BACKGROUND

• Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

  PMID: 26167730 BACKGROUND

• Gottesman E, McCool FD. Ultrasound evaluation of the paralyzed diaphragm. Am J Respir Crit Care Med. 1997 May;155(5):1570-4. doi: 10.1164/ajrccm.155.5.9154859.

  PMID: 9154859 BACKGROUND

• Summerhill EM, El-Sameed YA, Glidden TJ, McCool FD. Monitoring recovery from diaphragm paralysis with ultrasound. Chest. 2008 Mar;133(3):737-43. doi: 10.1378/chest.07-2200. Epub 2008 Jan 15.

  PMID: 18198248 BACKGROUND

• Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.

  PMID: 8553271 BACKGROUND

• Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.

  PMID: 22476448 BACKGROUND

• Wait JL, Nahormek PA, Yost WT, Rochester DP. Diaphragmatic thickness-lung volume relationship in vivo. J Appl Physiol (1985). 1989 Oct;67(4):1560-8. doi: 10.1152/jappl.1989.67.4.1560.

  PMID: 2676955 BACKGROUND

• 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

• Noh DK, Lee JJ, You JH. Diaphragm breathing movement measurement using ultrasound and radiographic imaging: a concurrent validity. Biomed Mater Eng. 2014;24(1):947-52. doi: 10.3233/BME-130889.

  PMID: 24211983 BACKGROUND

• Scott S, Fuld JP, Carter R, McEntegart M, MacFarlane NG. Diaphragm ultrasonography as an alternative to whole-body plethysmography in pulmonary function testing. J Ultrasound Med. 2006 Feb;25(2):225-32. doi: 10.7863/jum.2006.25.2.225.

  PMID: 16439786 BACKGROUND

• Gerscovich EO, Cronan M, McGahan JP, Jain K, Jones CD, McDonald C. Ultrasonographic evaluation of diaphragmatic motion. J Ultrasound Med. 2001 Jun;20(6):597-604. doi: 10.7863/jum.2001.20.6.597.

  PMID: 11400933 BACKGROUND

• Da Conceicao D, Perlas A, Giron Arango L, Wild K, Li Q, Huszti E, Chowdhury J, Chan V. Validation of a novel point-of-care ultrasound method to assess diaphragmatic excursion. Reg Anesth Pain Med. 2024 Nov 4;49(11):800-804. doi: 10.1136/rapm-2023-104983.

  PMID: 37940349 DERIVED

MeSH Terms

Interventions

Respiratory Function Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anahi Perlas, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: June 9, 2017
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CA (1)