Airway Management With Supraglottic Devices in Unruptured... | NCT03632902

Studies
Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms

NCT03632902

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Status

Completed

Last Update Posted

May 28, 2020Actual

Enrollment

205Actual

Phase

Not provided

Conditions

Airway Management

Interventions

supraglottic device

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

May 2020

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

Jun 26, 2018Actual

Primary Completion Date

Oct 20, 2019Actual

Completion Date

Nov 20, 2019Actual

First Submitted Date

Jun 26, 2018

First Submission Date that Met QC Criteria

Aug 12, 2018

First Posted Date

Aug 16, 2018Actual

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

May 27, 2020

Last Update Posted Date

May 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ricard Valero, head of neuroanesthesia section, 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

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Endovascular techniques for the treatment of intracranial aneurysms are growing.

Detailed Description

Retrospective analysis of the investigators experience in the last 8 years with the airway management in endovascular therapy for unruptured aneurysms. A total of 206 participants will be included from 2010 to 2018. Airway management (anticipated difficult airway, need for LM repositioning, orotracheal intubation because of failed laryngeal mask insertion, airway complication), intraoperative monitoring, aneurism size and location, intraoperative and perioperative complications will be registered.

Statistics will be compared between groups with t test or x 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

205Actual

Name	Type	Description	Arm Group Labels	Other Names
supraglottic device	Device	airway management will be collected

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Security in the use of supraglottic devices in the unruptured intracranial aneurysms.	security; the incidence of adverse events during the procedure and post-procedure will be recorded, also morbidity and mortality in patients managed with supraglottic devices during unruptured aneurysm embolization	ten years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients that underwent endovascular treatment for unruptured aneurysm

Exclusion Criteria:

ruptured aneurysm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent endovascular treatment for unruptured aneurysm in the past 8 years in our institution

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PAOLA A HURTADO RESTREPO, md	anesthesiologist in Hospital Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic		Barcelona	Catalonia	08019	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