Thoracic Spine DisorderULTRRANCT05968950
Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?
A study testing Thoracic ultrasound in people with Thoracic Spine Disorder, run by Cambridge University Hospitals NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thoracic Spine Disorder
- What is being tested?
- Thoracic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Dec 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic spine surgery
Who cannot join
- Paediatric patients or patients who are unable to give consent
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Thoracic Spine Disorder
- Being tested
- Thoracic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic ultrasoundDevice
The use of ultrasound to count ribs in order to surface mark the corresponding spinal level
| Study group | Role | What they receive |
|---|---|---|
| Thoracic spine ultrasound localization | Experimental | Single arm where patients undergo both types of skin localization Experimental ( Ultrasound ) correlating with standard of care which is Thoracic spine fluoroscopy Receives: Device: Thoracic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin
Measured: This binary data will be collected during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Spine DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, cohort
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bolem Nagarjun, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968950
- Sponsor's protocol ID
- A096602
- Acronym
- ULTRRA
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No intention to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?
- ClinicalTrials.gov ID
- NCT05968950
- Acronym / sponsor ID
- ULTRRA / A096602
- Conditions
- Thoracic Spine Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, cohort
| Arm | Type | Receives |
|---|---|---|
| Thoracic spine ultrasound localization | Experimental | Device: Thoracic ultrasoundSingle arm where patients undergo both types of skin localization Experimental ( Ultrasound ) correlating with standard of care which is Thoracic spine fluoroscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic spine surgery
Key exclusion criteria (1 listed)
- Paediatric patients or patients who are unable to give consent
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 |
|---|---|---|
| Thoracic ultrasoundThe use of ultrasound to count ribs in order to surface mark the corresponding spinal level | Device | Thoracic spine ultrasound localization |
Primary outcome
Accuracy
Time frame: This binary data will be collected during surgery
To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. No intention to share individual data
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic ultrasound in people with Thoracic Spine Disorder, run by Cambridge University Hospitals NHS Foundation Trust.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Accuracy (time frame: This binary data will be collected during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.