Elective Surgical ProcedurePhase 1NCT00355173
Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
A Phase 1 study testing Lubo cervical collar in people with Elective Surgical Procedure, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Elective Surgical Procedure
- What is being tested?
- Lubo cervical collar
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Elective Surgical Procedure
- Being tested
- Lubo cervical collar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubo cervical collarDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startMay 2006
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Omri Lubovsky, M.D., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355173
- Sponsor's protocol ID
- LB001-HMO-CTIL
- Status last verified
- Feb 2010
- First submitted
- 20 Jul 2006
- Last updated
- 12 May 2011
- Results posted
- No
Publications
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.
PubMed 20409626
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Efficacy and Safety of the Lubo Cervical Collar
- ClinicalTrials.gov ID
- NCT00355173
- Acronym / sponsor ID
- LB001-HMO-CTIL
- Conditions
- Elective Surgical Procedure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lubo cervical collar | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
- Derived from this study: PubMed 20409626Lubovsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omri Lubovsky, M.D. principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lubo cervical collar in people with Elective Surgical Procedure, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00355173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.