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

Phase 1

Completed

• Conditions: Elective Surgical Procedure

• Registration Number: NCT00355173
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-07-20
• Study First Submitted QC: 2006-07-20
• Study First Posted: 2006-07-21
• Status Verified: 2010-02
• Study Completion: 2010-11
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel