Laryngeal Mask Use in Knee-chest Position in Lumbar Surge... | NCT02162368

Studies
Laryngeal Mask Use in Knee-chest Position in Lumbar Surgery in Neurosurgical Patients

NCT02162368

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

358Actual

Phase

Not provided

Conditions

Airway Management
Spine Surgery
Prone Position

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Oct 2013Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jun 11, 2014

First Submission Date that Met QC Criteria

Jun 11, 2014

First Posted Date

Jun 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ricard Valero, Ricard Valero, MD, PhD, Fundacion Clinic per a la Recerca BiomédicaPrincipal Investigator

Lead Sponsor

Fundacion Clinic per a la Recerca BiomédicaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

358Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective spinal surgery

Exclusion Criteria:

emergency cases
complex spine surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent scheduled spine surgery in prone position

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricard Valero, MD, PhD	Head of neuroanesthesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesia department, Hospital Clínic de Barcelona		Barcelona	Barcelona	08036	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided