Airway ManagementNCT02162368
Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients
An observational study of Airway Management and Spine Surgery, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen the patient self-position to avoid complications such as accidental extubation or loss of the iv line. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, Spine Surgery, Prone Position
- How many people
- 358 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Nov 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent scheduled spine surgery in prone position
Who may be able to join
- elective spinal surgery
Who cannot join
- emergency cases
- complex spine surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
Anesthesia department, Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
About this study
Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen the patient self-position to avoid complications such as accidental extubation or loss of the iv line. The aim of our retrospective study is to describe our experience in the laryngeal mask use for airway management in patient submitted to spine surgery in neurosurgery
Read the detailed description
Retrospective analysis of our experience in the last 8 years with the airway management in spine surgery in prone position. A total of 358 cases were reviewed from 2008 to 2013.
Airway management (need for LM repositioning, orotracheal intubation because of failed LM insertion), anticipated difficult airway, and airway complications were registered. Statistics were compared between groups with the t test or the χ test, as appropriate.
- Conditions
- Airway Management, Spine Surgery, Prone Position
- Keywords
- laryngeal mask, prone position, spine surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
safety in the use of laryngeal mask in knee chest position in spine surgery
Analyse in a 3 years period of time, the incidence of complications in patients submitted to spinal surgery with tracheal intubation versus Laryngeal mask in prone position.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJan 2008
- Primary completionOct 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricard Valero, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Ricard Valero, MD, PhD, Principal investigator, Head of neuroanesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162368
- Sponsor's protocol ID
- HCB/2014/0097
- Status last verified
- Feb 2017
- First submitted
- 11 Jun 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT02162368
- Acronym / sponsor ID
- HCB/2014/0097
- Conditions
- Airway Management, Spine Surgery, Prone Position
- Keywords
- laryngeal mask, prone position, spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Jun 2014 (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.
Spine surgery is the most common procedure in neurosurgical setting. Some centers have chosen the patient self-position to avoid complications such as accidental extubation or loss of the iv line. The aim of our retrospective study is to describe our experience in the laryngeal mask use for airway management in patient submitted to spine surgery in neurosurgery
Detailed description
Retrospective analysis of our experience in the last 8 years with the airway management in spine surgery in prone position. A total of 358 cases were reviewed from 2008 to 2013.
Airway management (need for LM repositioning, orotracheal intubation because of failed LM insertion), anticipated difficult airway, and airway complications were registered. Statistics were compared between groups with the t test or the χ test, as appropriate.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent scheduled spine surgery in prone position
Key inclusion criteria (1 listed)
- elective spinal surgery
Key exclusion criteria (2 listed)
- emergency cases
- complex spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
safety in the use of laryngeal mask in knee chest position in spine surgery
Time frame: 3 years
Analyse in a 3 years period of time, the incidence of complications in patients submitted to spinal surgery with tracheal intubation versus Laryngeal mask in prone position.
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 14 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Ricard Valero, MD, PhD principal investigator
Head of neuroanesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Spine Surgery, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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 1 inclusion and 2 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 14 Feb 2017. 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 Spain. 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.
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.
What does the primary outcome measure?
safety in the use of laryngeal mask in knee chest position in spine surgery (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2017.