Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable? (ULTRRA)
Primary Purpose
Thoracic Spine Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thoracic ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Spine Disorder
Eligibility Criteria
Inclusion Criteria: Patients undergoing thoracic spine surgery Exclusion Criteria: Paediatric patients or patients who are unable to give consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thoracic spine ultrasound localization
Arm Description
Single arm where patients undergo both types of skin localization Experimental ( Ultrasound ) correlating with standard of care which is Thoracic spine fluoroscopy
Outcomes
Primary Outcome Measures
Accuracy
To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin
Secondary Outcome Measures
Full Information
NCT ID
NCT05968950
First Posted
July 12, 2023
Last Updated
July 29, 2023
Sponsor
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05968950
Brief Title
Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?
Acronym
ULTRRA
Official Title
Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial is to see if the investigators can find a safer and quicker way to localize the correct spinal level before the start of thoracic spinal surgery.
Currently, this localization is done with the help of spinal needles and fluoroscopy. There are some inherent issues with accuracy due to individual factors such as the type of operating table or the body habitus.
The investigators want to know if the use of ultrasound to count ribs and mark the corresponding spinal level would be a quicker and possibly even more accurate than the use of fluoroscopy.
Participants who will be approached for this study are those that have already consented to undergo thoracic spinal surgery. Once they have been consented for the study, they will undergo anesthesia as per normal and positioned prone for the intended surgery.
At this juncture, the radiographers will be setting up to perform fluoroscopy to confirm the spinal level and for the surgeons to mark the skin. For the purposes of the study, the investigators will use the ultrasound to count the ribs and mark the corresponding spinal level.
Participants will undergo fluoroscopy to mark the skin level as well. The investigators are studying to see if the ultrasound method is just as accurate as the traditional fluoroscopy method. The results will be binary and will be recorded. The study ends at this point and no further participation is required from the patient.
Detailed Description
Background & Rationale
Preoperative localization using spinal needles and fluoroscopy is the conventional method of performing the level check prior to the start of the surgery, with variations including the insertion of radio-opaque markers utilized in some units. Spinal needles are placed either over the skin or inserted directly into the body prior to taking an xray to confirm that the correct spinal levels are identified. The appropriate levels are marked on the skin and the incision is subsequently planned. All techniques currently used employ ionizing radiation, at potentially high doses. In the investigator's experience, they find that due to the various factors which include the type of operating table or frame, the body habitus of the patient (in particular, greater degrees of thoracic kyphosis, and obesity), the inadequacy of the xray images to cover the entire rib cage and the presence of arms tucked to the side often make the localization process tedious and often leaves us with a certain degree of uncertainty.
Ultrasound has been used by various specialties, most notably by anaesthetists and pain specialties to perform point of care interventions to thoracic vertebrae. Ultrasound has also been used in the thoracic region to diagnose rib fractures. Counting the rib levels to localize the appropriate thoracic vertebral level was devised as a progression on these methods.
By showing that the use of ultrasound to count the ribs is a quick and accurate way to localize the appropriate spinal level, the need to expose patients to repeated doses of radiation can be eliminated.
The investigators hypothesize that the use of ultrasound will allow us to accurately determine the appropriate spinal level prior to the start of surgery by counting the ribs. This method will not only be precise, but it will also be quick, non-invasive, cheaper and will limit the amount of radiation that the patient is exposed to.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Spine Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thoracic spine ultrasound localization
Arm Type
Experimental
Arm Description
Single arm where patients undergo both types of skin localization Experimental ( Ultrasound ) correlating with standard of care which is Thoracic spine fluoroscopy
Intervention Type
Device
Intervention Name(s)
Thoracic ultrasound
Intervention Description
The use of ultrasound to count ribs in order to surface mark the corresponding spinal level
Primary Outcome Measure Information:
Title
Accuracy
Description
To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin
Time Frame
This binary data will be collected during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing thoracic spine surgery
Exclusion Criteria:
Paediatric patients or patients who are unable to give consent
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No intention to share individual data
Learn more about this trial
Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?
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