NCT00355173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 12, 2011

Status Verified

February 1, 2010

First QC Date

July 20, 2006

Last Update Submit

May 11, 2011

Conditions

Elective Surgical Procedure

Interventions

Lubo cervical collarDEVICE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20409626DERIVED

Study Officials

  • Omri Lubovsky, M.D.

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 21, 2006

Study Start

May 1, 2006

Study Completion

November 1, 2010

Last Updated

May 12, 2011

Record last verified: 2010-02

Locations

IL(1)