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OpenTrials
Completed

NCT Number: NCT00355173

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubo cervical collar

Device

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2006
Study completion
2010
First posted
Jul 21, 2006
Registry last updated
May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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