Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-04 @ 11:54 PM
Study NCT ID:
NCT02617394
Status:
TERMINATED
Last Update Posted:
2020-03-25
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel vs. Traditional US Diaphragm Scanning
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Comparing Two Ultrasound-based Methods to Assess Diaphragm Movement
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI no longer at institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: