Ultrasound Localization in Thoracic Surgery - is Radiation Reduction Achievable?

NCT05968950 | Unknown DMC

• 1 other identifier: A096602
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thoracic Spine Disorder

Outcome Measures

Primary Outcomes (1)

• Accuracy

  To correlate with standard of care (fluoroscopy) - to ensure correct spinal levels marked on the skin

  This binary data will be collected during surgery

Study Arms (1)

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

Device: Thoracic ultrasound

Interventions

Thoracic ultrasound DEVICE

The use of ultrasound to count ribs in order to surface mark the corresponding spinal level

Thoracic spine ultrasound localization

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing thoracic spine surgery

You may not qualify if:

• Paediatric patients or patients who are unable to give consent

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Division of Neurosurgery, Principal Investigator

Model Details: Prospective, cohort

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share