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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
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Spine Disorder

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 12, 2023
    Last Updated
    July 29, 2023
    Sponsor
    Cambridge University Hospitals NHS Foundation Trust
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    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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