Airway ManagementNCT03632902
Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms
An observational study of Airway Management, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Endovascular techniques for the treatment of intracranial aneurysms are growing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Airway Management
- What is being tested?
- supraglottic device
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jun 2018to 20 Nov 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent endovascular treatment for unruptured aneurysm in the past 8 years in our institution
Who may be able to join
- patients that underwent endovascular treatment for unruptured aneurysm
Who cannot join
- ruptured aneurysm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysm Endovascular Therapy
Endovascular techniques for the treatment of intracranial aneurysms are growing.
Read the 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.
- Conditions
- Airway Management
- Being tested
- supraglottic device
- Keywords
- supraglottic devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic deviceDevice
airway management will be collected
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start26 Jun 2018
- Primary completion20 Oct 2019
- Study completion20 Nov 2019
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 205 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
- PAOLA A HURTADO RESTREPO, md, Principal investigator, anesthesiologist in Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632902
- Sponsor's protocol ID
- HCB/2018/0691
- Status last verified
- May 2020
- First submitted
- 26 Jun 2018
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysm Endovascular Therapy
- ClinicalTrials.gov ID
- NCT03632902
- Acronym / sponsor ID
- HCB/2018/0691
- Conditions
- Airway Management
- Keywords
- supraglottic devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent endovascular treatment for unruptured aneurysm in the past 8 years in our institution
Key inclusion criteria (1 listed)
- patients that underwent endovascular treatment for unruptured aneurysm
Key exclusion criteria (1 listed)
- ruptured aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supraglottic deviceairway management will be collected | Device | – |
Primary outcome
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
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 28 May 2020.
- 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.
PAOLA A HURTADO RESTREPO, md principal investigator
anesthesiologist in Hospital Clinic
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, 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 1 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 28 May 2020. 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?
Security in the use of supraglottic devices in the unruptured intracranial aneurysms. (time frame: ten 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 28 May 2020.