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

Elective Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355173
• Other study ID #: LB001-HMO-CTIL
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2006
• Last updated: May 11, 2011
• Start date: May 2006
• Est. completion date: November 2010

Study information

• Verified date: February 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Surgical Procedure

Intervention

Device:
• Lubo cervical collar

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,