Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 20, 2011 | ||||
| Last Updated Date | March 16, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] - 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01342575 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery | ||||
| Official Title ICMJE | Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery. Comparison of the Podalic Compression and Shoulder Traction Maneuvers | ||||
| Brief Summary | The purpose of this study is to establish which of five different maneuvers could bring the best trans-operatory x-ray exposure during anterior cervical surgeries with the higher security |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Cervical Disk Disease | ||||
| Intervention ICMJE | Procedure: Intra-operative exposure maneuvers
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| Study Arm (s) | Experimental: Intra-operative maneuver group
Intervention: Procedure: Intra-operative exposure maneuvers |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Mexico | ||||
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| Administrative Information | |||||
| NCT Number ICMJE | NCT01342575 | ||||
| Other Study ID Numbers ICMJE | ABC-11-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Galvan Ernesto Eduardo, American British Cowdray Medical Center | ||||
| Study Sponsor ICMJE | American British Cowdray Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | American British Cowdray Medical Center | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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