Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms

Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysm Endovascular Therapy

Endovascular techniques for the treatment of intracranial aneurysms are growing.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: supraglottic device

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.

• Study Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08019
      • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• patients that underwent endovascular treatment for unruptured aneurysm

Exclusion Criteria:

• ruptured aneurysm

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Investigators: Principal Investigator: PAOLA A HURTADO RESTREPO, md, anesthesiologist in Hospital Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2018
• Primary Completion (ACTUAL): October 20, 2019
• Study Completion (ACTUAL): November 20, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: supraglottic devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: HCB/2018/0691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No