Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00355173

Purpose

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.

Condition	Intervention	Phase
Elective Surgical Procedure	Device: Lubo cervical collar	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar

Further study details as provided by Hadassah Medical Organization:

Study Start Date:	May 2006
Estimated Study Completion Date:	November 2009

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355173

Contacts

Contact: Omri Lubovsky, M.D.

+972-2-6776292

OMRI@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD 00 972 2 6779095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00-972-2-67776572 lhadas@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Omri Lubovsky, M.D.

Hadassah Medical Organization

More Information

Study ID Numbers:	LB001-HMO-CTIL
Study First Received:	July 20, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00355173
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on January 14, 2009