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Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery

This study is currently recruiting participants.
Verified March 2012 by American British Cowdray Medical Center
Sponsor:
Information provided by (Responsible Party):
Galvan Ernesto Eduardo, American British Cowdray Medical Center
ClinicalTrials.gov Identifier:
NCT01342575
First received: April 20, 2011
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention
Cervical Disk Disease
 Procedure: Intra-operative exposure maneuvers

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improvement of Trans-operatory X-ray Visualization During Anterior Cervical Surgery. Comparison of the Podalic Compression and Shoulder Traction Maneuvers

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by American British Cowdray Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-operative maneuver group Procedure: Intra-operative exposure maneuvers
  • Feet compression maneuver: Taking feet from the ankles, gentle pressure will be applied toward the cranium and maintained for 1 minute. X-rays and IONM will be performed
  • Arm traction maneuver: Holding two strips around the wrists and using a dynamometer adjusted to 8 kg per side, sustained traction will be maintained for 1 minute. X-rays and IONM will be performed.
  • Shoulder taping maneuver: Both shoulders will be pulled caudally with adhesive tape adjusted for a tension of 8 kg on each side. X-rays and IONM will be performed
  • Arm traction plus feet compression maneuvers: Simultaneous combination of both maneuvers as described before. X-rays and IONM will be performed
  • Shoulder taping plus feet compression maneuvers: Simultaneous combination of both maneuvers as described before. X-rays and IONM will be performed

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342575

Contacts
Contact: Ernesto E Galvan Hernandez, MD, MsC 52 (55) 16647205 ext 4155 egalh@yahoo.com

Locations
Mexico
American British Cowdray Medical Center, Neurological Center Recruiting
Mexico City, D.F, Mexico, 05300
Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC            
Sub-Investigator: Roberto De Leo, MD            
Sub-Investigator: Miguel Angel Collado Corona, MD            
Sub-Investigator: Leopoldo Torres Vieyra, MD            
Sub-Investigator: Maximino Tellez Gutierrez, MD            
Sub-Investigator: Ildelfonso Muñoz Romero, MD            
Sponsors and Collaborators
American British Cowdray Medical Center
Investigators
Principal Investigator: Ernesto E Galvan Hernandez, MD, MsC American British Cowdray Medical Center, Neurological Center
  More Information

Publications:

Responsible Party: Galvan Ernesto Eduardo, MD, American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT01342575     History of Changes
Other Study ID Numbers: ABC-11-02
Study First Received: April 20, 2011
Last Updated: March 16, 2012
Health Authority: Mexico: American British Cowdray Review Board

Keywords provided by American British Cowdray Medical Center:
ACDF

ClinicalTrials.gov processed this record on May 16, 2013