- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342575
Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery
Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery. Comparison of the Podalic Compression and Shoulder Traction Maneuvers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Anterior cervical spine surgery (ACSS) is one of the most common spine surgery performed by neurosurgeons. One of the challenging aspects during ACSS is to achieve a correct visualization and identification of the lower levels specifically below the fifth and sixth cervical vertebras due to the difficulty of penetrating X-ray beams through the shoulders. Several methods such as taping the shoulders throughout the entire case or tying straps around the wrists and pulling them caudally temporally while shooting X-rays have been used trying to improve visualization during surgery. Both of these methods may cause problems such as brachial plexus injury, shoulder dislocations and peripheral nerve injuries.
The feet compression maneuver will be tested in terms of it's efficacy and security, as well as compared with four previous described maneuvers, using intra-operative neurophysiology monitoring (IONM).
50 consecutive patients programmed for elective ACSS that could meet inclusion criteria will be monitored with IONM using transcranial electric motor evoked potentials (tceMEPs), somatosensory evoked potentials (SSEPs) and spontaneous electromyography (EMG) after total endovenous anesthesia. On the operating table, a basal lateral x-ray picture and a first determination of IONM will be performed and used for comparison. Five maneuvers will be sequentially performed: 1) Feet compression, 2) Arm traction, 3) Arm traction plus feet compression combined, 4) Shoulder taping and 5) Shoulder taping plus feet compression.
All five maneuvers will be maintained for 1 min, time during IONM will test for changes in voltage amplitude and duration that potentially could be risky (risky is defined as a change in determinations more than 50% compared to basal determinations). Lateral x-rays will be performed during each maneuver to measure changes in segments visualization and levels exposed.
After all maneuvers are completed, we will proceed as the surgery was scheduled.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ernesto E Galvan Hernandez, MD, MsC
- Phone Number: 4155 52 (55) 16647205
- Email: egalh@yahoo.com
Study Locations
-
-
D.F
-
Mexico City, D.F, Mexico, 05300
- Recruiting
- American British Cowdray Medical Center, Neurological Center
-
Sub-Investigator:
- Leopoldo Torres Vieyra, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with any stable biomechanically cervical pathology (like disk herniations, vertebral tumors, etc.), scheduled for ACSS
Exclusion Criteria:
- Any cervical pathology associated with segmental instability
- History of shoulder, arm, elbow or wrist pathology, including surgery or implants.
- Radiological signs of myelopathy by MRI or clinically detected
- Preoperative identified neurological deficit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intra-operative maneuver group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra operative neurophysiological monitoring (IONM) alert
Time Frame: Participants will be followed for the duration of the surgical procedure, an expected average of 3-4 hours
|
- Real time neurophysiological monitoring will be performed using evoked potentials during the whole case, specially registered during all five maneuvers.
This continuous electrical surveillance let us identify any potential risk to spinal cord or nerves, founded like an IONM alert (defined as nerve irritation or a decrease in voltage and/or amplitude response).
This is a single and immediate measurement obtained at surgery and it is a safety issue.
|
Participants will be followed for the duration of the surgical procedure, an expected average of 3-4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of segmental exposure on cervical spine lateral x-rays
Time Frame: Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours
|
During surgery, on each of the five maneuvers, a lateral x-ray will be taken to assess the percent of visualization of the more inferior vertebra possible to see. At the surgical room, with the basal and the 5 experimental X-rays on hands, percent of exposure will be measured. Results will be recorded at the time of the surgery and presented showing any electrical change registered by IONM during the 5 maneuvers. |
Participants will be followed for the duration of surgical procedure, an expected average of 3-4 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC, American British Cowdray Medical Center, Neurological Center
Publications and helpful links
General Publications
- Collado-Corona MA, de Leo-Vargas R, Sandoval-Sanchez V, Diaz-Hernandez A, Gutierrez-Sougarret BJ, Shkurovich-Bialik P. Neurophysiological monitoring in spinal cord surgery. Cir Cir. 2009 Sep-Oct;77(5):385-90.
- Lee JY, Hilibrand AS, Lim MR, Zavatsky J, Zeiller S, Schwartz DM, Vaccaro AR, Anderson DG, Albert TJ. Characterization of neurophysiologic alerts during anterior cervical spine surgery. Spine (Phila Pa 1976). 2006 Aug 1;31(17):1916-22. doi: 10.1097/01.brs.0000228724.01795.a2.
- Schwartz DM, Sestokas AK, Hilibrand AS, Vaccaro AR, Bose B, Li M, Albert TJ. Neurophysiological identification of position-induced neurologic injury during anterior cervical spine surgery. J Clin Monit Comput. 2006 Dec;20(6):437-44. doi: 10.1007/s10877-006-9032-1. Epub 2006 Sep 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ABC-11-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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