Elective Surgical Procedure
Conditions
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 control and airway protection in the trauma patient.
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 airway manipulations. Definitive airway protection usually must be achieved by orotracheal intubation. Thee Lubo collar is a device that simultaneously maintains cervical spine control and keeps an open airway in a non-invasive manner that is simple to operate. The objective of the study is to test the safety of the collar volunteers. The study is composed of two stages:1.healthy volunteers that will not undergo any intervention except testing the LCC.2. second group of patients scheduled to undergo an operation under general anesthesia with endotracheal intubation or laryngeal mask airway.
Interventions
DEVICELubo cervical collar
Sponsors
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females. 2. Age 18-60. 3. Normal airway anatomy, with expected easy ventilation and intubation. 4. Anesthetic risk- class 1or 2 by the American Society of Anesthesiologists (ASA) criteria. 5. Patients scheduled for an elective operation at the lower part of the body in supine position not supposed to last more then 2 hours. 6. Anesthetic plan- general anesthesia
Exclusion criteria
1. Known problems of the cervical spine. 2. Known problems of the temporomandibular joint. 3. Suspected difficult intubation or difficult mask ventilation. 4. High risk of gastric content aspiration. 5. Morbid obesity (BMI \>32). 6. Pregnancy 7. Psycho- social problems 8. Any cerebrovascular or cardiovascular disease 9. Known hypersensitivity reactions to fabrics or plastics 10. Any rash, eruption, wounds or sores at the upper torso, the neck and the head. 11. No participation in other clinical trail at the time of the trail
Countries
Israel
Outcome results
None listed