Diaphragm; MovementNCT03225508
Diaphragmatic Motion Using Linear Ultrasound
An observational study of Diaphragm; Movement and Examination of Diaphragm Movement Using Ultrasound, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm; Movement, Examination of Diaphragm Movement Using Ultrasound
- What is being tested?
- Linear Ultrasound to Measure Diaphragmatic Movement, Curvilinear Ultrasound to Measure Diaphragmatic Movement and Pulmonary function tests
- Type of treatment
- Injection or infusion
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jun 2017to 23 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Method to Measure Diaphragmatic Motion and Excursion
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.
Read the detailed description
Background:
Multiple pathologies cause diaphragmatic dysfunction, including: respiratory, abdominal and neurological disease. Established clinical tests of diaphragmatic function, include: the transdiaphragmatic pressure, the maximal static inspiratory pressure, the sniff inspiratory pressure, pulmonary function tests, electromyography, a chest radiograph or fluoroscopy.
However ultrasound assessment of diaphragmatic function is a non-invasive, radiation-free technique that has gained traction in clinical practice in recent years. Several different methods have been described, that examine motion in two different areas of the diaphragm, either the zone of apposition, or the dome of the diaphragm, however no one method has emerged as the standard of care.
The current conventional technique (using B-mode or M-mode ultrasound via a phased array or curvilinear probe) in the subcostal region, has several limitations:
- It can be difficult to measure right hemi-diaphragm excursion with deep breathing, with a failure rate of up to 28% described for quantitative assessment.
- It is even more difficult to quantitatively assess left hemi-diaphragmatic excursion with deep breathing, as the spleen provides a smaller window compared to the liver window. Failure rates of 79% and 65% have been reported.
- When using M-mode, the ultrasound beam must image the diaphragmatic excursion line at a perpendicular angle, otherwise reproducibility and accuracy are adversely effected.
The investigators propose a novel method, using linear ultrasound to examine the zone of apposition, and determine diaphragmatic excursion at end inspiration and expiration. In theory this technique may have a number of advantages over the conventional method. It is likely easier to learn, quicker to perform, and has a lower failure rate for imaging the diaphragm on both sides during deep breathing. The investigators will compare this method to the conventional method, i.e. a curvilinear probe as described above.
Hypothesis:
Diaphragmatic motion can be assessed more rapidly, and more reliably via a linear high frequency ultrasound probe, than a curved low frequency probe.
Primary Objective:
- To evaluate the ease and success of using a novel technique of point-of-care ultrasound diaphragm assessment with a linear probe in the mid-axillary line to measure diaphragmatic motion. The ease of procedure will be determined by the time and the number of attempts required to perform the ultrasound assessment.
Secondary Objectives:
- To determine the normal range of diaphragmatic excursion values from full expiration to full inspiration in men and women;
- To quantify the reduction in diaphragmatic motion following phrenic nerve palsy - due to an interscalene, upper trunk or supraclavicular brachial plexus block;
- To compare the finding of diminished diaphragmatic excursion with the conventional method of measurement; i.e. compare the sensitivity and specificity of the tests.
- To analyze the success rate of measuring the left and right hemi-diaphragmatic movement as compared with the conventional method of measurement.
This prospective observational study, will involve patients undergoing elective surgery, and will consist of two phases:
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 for this technique in men and women.
Phase 2:
The second phase will involve 100 patients who are undergoing an inter-scalene, upper trunk of cervical plexus, or supraclavicular brachial plexus block as part of their perioperative analgesic management for shoulder or arm surgery. This cohort of patient is likely to develop phrenic nerve palsy as a side effect of the brachial plexus block. The resultant phrenic nerve palsy, will result in reduced diaphragmatic motion, and the aim will be to evaluate the ability of using a linear probe technique to measure this reduction as compared to the conventional method of measurement.
- Being tested
- Linear Ultrasound to Measure Diaphragmatic Movement, Curvilinear Ultrasound to Measure Diaphragmatic Movement, Pulmonary function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Ultrasound to Measure Diaphragmatic MovementDiagnostic 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.
Curvilinear Ultrasound to Measure Diaphragmatic MovementDiagnostic 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.
Pulmonary function testsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: Linear Ultrasound to Measure Diaphragmatic Movement; Diagnostic Test: Curvilinear Ultrasound to Measure Diaphragmatic Movement; Diagnostic Test: Pulmonary function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Secondary outcomes (3)
Normal range of values for diaphragmatic excursion using linear ultrasound
To determine the normal range of values for diaphragmatic excursion from end expiration to end inspiration in men and women
Measured: 30 mins
Quantify and compare the reduction in diaphragmatic motion following a phrenic nerve block
To quantify and compare the reduction in diaphragmatic motion (% change from baseline) following a phrenic nerve block using both linear and curved ultrasound probes
Measured: 2 hours
Success rate of measuring both the left and right hemi-diaphragmatic movement
To analyze the success rate of measuring both the left and right hemi-diaphragmatic movement; success is defined as successful capture of a good view of the diaphragm and its movement on sonogram using the B mode and M mode scan
Measured: 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start9 Jun 2017
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Diaphragm; MovementStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225508
- Sponsor's protocol ID
- 16-6385
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2017
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27216909Boussuges 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.
PubMed 19017880Kim 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.
PubMed 20418298Kim 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.
PubMed 21705883Lerolle 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.
PubMed 18753469Testa 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.
PubMed 21144957Baldwin 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.
PubMed 21645172DiNino 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.
PubMed 24365607Ferrari 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.
PubMed 24949192Goligher 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.
PubMed 26167730Gottesman 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.
PubMed 9154859Summerhill 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.
PubMed 18198248Ueki 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.
PubMed 8553271Vivier 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.
PubMed 22476448Wait 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.
PubMed 2676955
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method to Measure Diaphragmatic Motion and Excursion
- ClinicalTrials.gov ID
- NCT03225508
- Acronym / sponsor ID
- 16-6385
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Multiple pathologies cause diaphragmatic dysfunction, including: respiratory, abdominal and neurological disease. Established clinical tests of diaphragmatic function, include: the transdiaphragmatic pressure, the maximal static inspiratory pressure, the sniff inspiratory pressure, pulmonary function tests, electromyography, a chest radiograph or fluoroscopy.
However ultrasound assessment of diaphragmatic function is a non-invasive, radiation-free technique that has gained traction in clinical practice in recent years. Several different methods have been described, that examine motion in two different areas of the diaphragm, either the zone of apposition, or the dome of the diaphragm, however no one method has emerged as the standard of care.
The current conventional technique (using B-mode or M-mode ultrasound via a phased array or curvilinear probe) in the subcostal region, has several limitations:
- It can be difficult to measure right hemi-diaphragm excursion with deep breathing, with a failure rate of up to 28% described for quantitative assessment.
- It is even more difficult to quantitatively assess left hemi-diaphragmatic excursion with deep breathing, as the spleen provides a smaller window compared to the liver window. Failure rates of 79% and 65% have been reported.
- When using M-mode, the ultrasound beam must image the diaphragmatic excursion line at a perpendicular angle, otherwise reproducibility and accuracy are adversely effected.
The investigators propose a novel method, using linear ultrasound to examine the zone of apposition, and determine diaphragmatic excursion at end inspiration and expiration. In theory this technique may have a number of advantages over the conventional method. It is likely easier to learn, quicker to perform, and has a lower failure rate for imaging the diaphragm on both sides during deep breathing. The investigators will compare this method to the conventional method, i.e. a curvilinear probe as described above.
Hypothesis:
Diaphragmatic motion can be assessed more rapidly, and more reliably via a linear high frequency ultrasound probe, than a curved low frequency probe.
Primary Objective:
- To evaluate the ease and success of using a novel technique of point-of-care ultrasound diaphragm assessment with a linear probe in the mid-axillary line to measure diaphragmatic motion. The ease of procedure will be determined by the time and the number of attempts required to perform the ultrasound assessment.
Secondary Objectives:
- To determine the normal range of diaphragmatic excursion values from full expiration to full inspiration in men and women;
- To quantify the reduction in diaphragmatic motion following phrenic nerve palsy - due to an interscalene, upper trunk or supraclavicular brachial plexus block;
- To compare the finding of diminished diaphragmatic excursion with the conventional method of measurement; i.e. compare the sensitivity and specificity of the tests.
- To analyze the success rate of measuring the left and right hemi-diaphragmatic movement as compared with the conventional method of measurement.
This prospective observational study, will involve patients undergoing elective surgery, and will consist of two phases:
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 for this technique in men and women.
Phase 2:
The second phase will involve 100 patients who are undergoing an inter-scalene, upper trunk of cervical plexus, or supraclavicular brachial plexus block as part of their perioperative analgesic management for shoulder or arm surgery. This cohort of patient is likely to develop phrenic nerve palsy as a side effect of the brachial plexus block. The resultant phrenic nerve palsy, will result in reduced diaphragmatic motion, and the aim will be to evaluate the ability of using a linear probe technique to measure this reduction as compared to the conventional method of measurement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Diagnostic Test: Linear Ultrasound to Measure Diaphragmatic Movement, Diagnostic Test: Curvilinear Ultrasound to Measure Diaphragmatic MovementThe 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 |
| Phase 2 | – | Diagnostic Test: Linear Ultrasound to Measure Diaphragmatic Movement, Diagnostic Test: Curvilinear Ultrasound to Measure Diaphragmatic Movement, Diagnostic Test: Pulmonary function testsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linear Ultrasound to Measure Diaphragmatic MovementA 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. | Diagnostic test | Phase 1, Phase 2 |
| Curvilinear Ultrasound to Measure Diaphragmatic MovementA 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. | Diagnostic test | Phase 1, Phase 2 |
| Pulmonary function testsBedside 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. | Diagnostic test | Phase 2 |
Primary outcome
Time taken to measure diaphragmatic excursion
Time frame: 60 minutes
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.
3 secondary outcomes
Normal range of values for diaphragmatic excursion using linear ultrasound
Time frame: 30 mins
Quantify and compare the reduction in diaphragmatic motion following a phrenic nerve block
Time frame: 2 hours
Success rate of measuring both the left and right hemi-diaphragmatic movement
Time frame: 60 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 27216909Sferrazza 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.
- Background: PubMed 19017880Boussuges 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.
- Background: PubMed 20418298Kim 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.
- Background: PubMed 21705883Kim 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.
- Background: PubMed 18753469Lerolle 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.
- Background: PubMed 21144957Testa 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.
- Background: PubMed 21645172Baldwin 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.
- Background: PubMed 24365607DiNino 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.
- Background: PubMed 24949192Ferrari 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.
- Background: PubMed 26167730Goligher 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.
- Background: PubMed 9154859Gottesman 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.
- Background: PubMed 18198248Summerhill 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anahi Perlas, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm; Movement and Examination of Diaphragm Movement Using Ultrasound, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to measure diaphragmatic excursion (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225508, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.