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Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms

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ClinicalTrials.gov Identifier: NCT03632902
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ricard Valero, Fundacion Clinic per a la Recerca Biomédica

Brief Summary:
Endovascular techniques for the treatment of intracranial aneurysms are growing.

Condition or disease Intervention/treatment
Airway Management 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
Estimated Enrollment : 205 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysm Endovascular Therapy
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : October 20, 2018
Estimated Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: supraglottic device
    airway management will be collected


Primary Outcome Measures :
  1. Security in the use of supraglottic devices in the unruptured intracranial aneurysms. [ Time Frame: ten years ]
    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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent endovascular treatment for unruptured aneurysm in the past 8 years in our institution
Criteria

Inclusion Criteria:

  • patients that underwent endovascular treatment for unruptured aneurysm

Exclusion Criteria:

  • ruptured aneurysm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632902


Contacts
Contact: PAOLA A HURTADO RESTREPO, MD 034932275558 phurtado@clinic.ub.es
Contact: ricard valero castell, phd

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Cataluña, Spain, 08019
Contact: PAOLA A HURTADO RESTREPO    034932275558    phurtado@clinic.ub.es   
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
Principal Investigator: PAOLA A HURTADO RESTREPO, md anesthesiologist in Hospital Clinic

Responsible Party: Ricard Valero, head of neuroanesthesia section, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03632902     History of Changes
Other Study ID Numbers: HCB/2018/0691
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Ricard Valero, Fundacion Clinic per a la Recerca Biomédica:
supraglottic devices

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases