Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar

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.

Study Overview

• Status: Completed
• Conditions: Elective Surgical Procedure
• Intervention / Treatment: Device: Lubo cervical collar

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Omri Lubovsky, M.D., Hadassah Medical Organization

Publications and helpful links

General Publications

• Lubovsky O, Liebergall M, Weissman C, Yuval M. A new external upper airway opening device combined with a cervical collar. Resuscitation. 2010 Jul;81(7):817-21. doi: 10.1016/j.resuscitation.2010.02.013. Epub 2010 Apr 20.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 20, 2006
• First Submitted That Met QC Criteria: July 20, 2006
• First Posted (Estimate): July 21, 2006

Study Record Updates

• Last Update Posted (Estimate): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 11, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: LB001-HMO-CTIL