Status:
COMPLETED
Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Elective Surgical Procedure
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The Lubo cervical collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner. The purpose of the device is to manage cervical spine contr...
Detailed Description
Cervical spine stabilization is usually achieved by a semi-rigid collar. While these collars achieve the goal of supporting the cervical spine, they limit the possibilities for jaw thrust or other air...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males or females.
- Age 18-60.
- Normal airway anatomy, with expected easy ventilation and intubation.
- Anesthetic risk- class 1or 2 by the American Society of Anesthesiologists (ASA) criteria.
- Patients scheduled for an elective operation at the lower part of the body in supine position not supposed to last more then 2 hours.
- Anesthetic plan- general anesthesia
- Exclusion criteria
- Known problems of the cervical spine.
- Known problems of the temporomandibular joint.
- Suspected difficult intubation or difficult mask ventilation.
- High risk of gastric content aspiration.
- Morbid obesity (BMI \>32).
- Pregnancy
- Psycho- social problems
- Any cerebrovascular or cardiovascular disease
- Known hypersensitivity reactions to fabrics or plastics
- Any rash, eruption, wounds or sores at the upper torso, the neck and the head.
- No participation in other clinical trail at the time of the trail
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00355173
Start Date
May 1 2006
End Date
November 1 2010
Last Update
May 12 2011
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120