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Respiratory DiaphragmNCT02617394

Novel vs. Traditional US Diaphragm Scanning

A study testing Diaphragm scanning - traditional method first and Diaphragm scanning - novel method first in people with Respiratory Diaphragm, run by University of Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Occasionally, doctors need to be able to see whether the diaphragm - a muscle in the chest that helps control breathing - is moving properly. If the diaphragm is paralyzed or not moving properly, this can affect a person's breathing. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Respiratory Diaphragm
What is being tested?
Diaphragm scanning - traditional method first and Diaphragm scanning - novel method first
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Nov 2015to Nov 2017
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient (18 years of age or older)
  • Provided informed consent
  • Supraclavicular block indicated for surgical anesthesia

Who cannot join

  • Refusal to provide consent

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

Official title: Comparing Two Ultrasound-based Methods to Assess Diaphragm Movement

Occasionally, doctors need to be able to see whether the diaphragm - a muscle in the chest that helps control breathing - is moving properly. If the diaphragm is paralyzed or not moving properly, this can affect a person's breathing. After certain nerve blocks - where a part of the body is frozen using local anesthetic - the nerve controlling diaphragm movement can be anesthetized, causing diaphragm paralysis. Ultrasound can be used to see the diaphragm and measure its movement, but the easiest and fastest way to do this is debatable. The investigators wish to compare two ultrasound-based methods to image diaphragm movement to see which one offers the quickest and easiest way to determine if the diaphragm is paralyzed.

Read the detailed description

Background and rationale The diaphragm muscle helps to control breathing: upon inhalation, the diaphragm contracts, helping to draw air into the lungs. Air is exhaled when the diaphragm relaxes. Measurement of diaphragmatic movement is an important tool in assessing function of the diaphragm. With the introduction of ultrasound technology to the bedside, the motion of the diaphragm and lungs can be visualized in real time. This affords practitioners the ability to detect when the diaphragm is paralyzed or is not moving properly. For example, the phrenic nerve, which controls diaphragm movement, is often anesthetized during interscalene brachial plexus block. As a result, the diaphragm on the block side is paralyzed, compromising breathing. This can have serious implications for patients who already suffer from respiratory difficulties.

There are several previously described methods for assessing diaphragm movement using ultrasound. The investigators wish to compare two methods to determine which one is more user-friendly and offers the fastest time to measure diaphragm movement. The first method will rely on the ability to identify and image the right and left diaphragms through the acoustic windows of the liver and spleen, respectively, and then record diaphragm movement in M-mode. The second method will rely on the ability to identify the location of the diaphragm by imaging lung sliding, followed by re-orientation of the ultrasound probe to enable measurement of changes in diaphragm thickness with respirations. The investigators hypothesize that, due to the more obvious visibility of the structures involved, the second method will result in more accurate confirmation of diaphragm paralysis.

Study objectives The primary objective is to determine which of two ultrasound-based methods of imaging the diaphragm offers the fastest and easiest way to confirm diaphragm paralysis. A secondary objective is to determine the inter-rater reliability among two individuals using the same scanning method.

Hypothesis The investigators hypothesize that imaging lung sliding with ultrasound followed by diaphragm thickness measurement will be easier and faster for practitioners to detect diaphragm motion/paralysis.

Study procedures Following informed written consent, eligible patients will be recruited in the University of Alberta pre-admission clinic (PAC) or day ward. Once the patient arrives in the block area, a study investigator will scan the patient's diaphragm on both sides using one of the two scanning methods. The scanning method to be used will be determined randomly; the investigator will be given a sealed envelope containing brief instructions on the method of diaphragm imaging to be used. The investigator will scan one side of the patient and then the other side. The order of scanning will be left to the participating investigator. A study team member will record the length of time taken for the investigator to obtain what they deem to be optimal images, which will be saved on the ultrasound machine. Following this, the regional block will be administered.

Once the regional block is deemed to be working, the second set of diaphragm scans will be done. A study investigator will be given brief instructions on how to perform the scanning method, which will be the same one done pre-block. Again, time taken to obtain optimal images will be recorded, and the images will be saved on the ultrasound machine. This will end the study procedure, and the patient will be transferred to the operating theater.

Being tested
Diaphragm scanning - traditional method first, Diaphragm scanning - novel method first

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragm scanning - traditional method firstOther

    The first (pre-block) diaphragm scan with ultrasound will be done on both sides using the liver (right side) and spleen (left side) as acoustic windows. The second (post-block) diaphragm scan will be done on both sides using a novel method in which lung sliding is used as a guide to identify the diaphragm and quantify diaphragm thickening upon respiration.

  • Diaphragm scanning - novel method firstOther

    The first (pre-block) diaphragm scan with ultrasound will be done on both sides using a novel method in which lung sliding is used as a guide to identify the diaphragm and quantify diaphragm thickening upon respiration. The second (post-block) diaphragm scan will be done will be done on both sides using the liver (right side) and spleen (left side) as acoustic windows.

Study groups in NCT02617394
Study groupRoleWhat they receive
Control groupActive comparatorNot described
Receives: Other: Diaphragm scanning - traditional method first
Study groupExperimentalNot described
Receives: Other: Diaphragm scanning - novel method first

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time taken to image diaphragm

    Total time will be from when the probe is placed on the patient's body to when a good quality image of the diaphragm is recorded. This will be done on each side of the body.

    Measured: Approximately 2-5 minutes from start of ultrasound scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Why it stopped: PI no longer at institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02617394
Sponsor's protocol ID
Pro00060267
Status last verified
Mar 2020
First submitted
24 Nov 2015
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Houston JG, Morris AD, Howie CA, Reid JL, McMillan N. Technical report: quantitative assessment of diaphragmatic movement--a reproducible method using ultrasound. Clin Radiol. 1992 Dec;46(6):405-7. doi: 10.1016/s0009-9260(05)80688-9. No abstract available.

    PubMed 1493655
  • 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.

    PubMed 21144957
  • 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.

    PubMed 23344830

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragm scanning - traditional method first and Diaphragm scanning - novel method first in people with Respiratory Diaphragm, run by University of Alberta 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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 was stopped early (reason given: PI no longer at institution). Results are not available in the source record.

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 image diaphragm (time frame: Approximately 2-5 minutes from start of ultrasound scan). 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 NCT02617394, which also lists 3 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 25 Mar 2020.

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