Cerebral Aneurysm UnrupturedNCT03288519
Use of Classic LMA During Endovascular Therapy
An observational study of Cerebral Aneurysm Unruptured and Cerebral Aneurysm, run by Universidad de Antioquia.
Trial summary
Background: Earlier treatment and resolution for patients with cerebral aneurysms is now possible due to earlier diagnosis. This observational study aims to evaluate the intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm Unruptured, Cerebral Aneurysm, Hemodynamic Instability
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 28 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An observational prospective study was undertaken in the Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic in Bello, Antioquia, Colombia. The investigators included patients ≥ 18 years old diagnosed with an unruptured cerebral aneurysm or SAH (Hunt \& Hess grade I or II) undergoing endovascular treatment under general anesthesia between April 2015 and February 2017. The investigators excluded patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and patients with SAH (Hunt \& Hess grade > II).
Who may be able to join
- Patients ≥ 18 years old
- Diagnosed with an unruptured cerebral aneurysm or SAH (Hunt \& Hess grade I or II)
- Planned to undergo endovascular therapy under general anesthesia between April 2015 and February 2017 in the Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic in Bello, Antioquia, Colombia
Who cannot join
- Patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and patients with SAH (Hunt \& Hess grade > II).
About this study
Official title: The Use of the Classic Laryngeal Mask Airway in Patients With Cerebral Aneurysm Undergoing Endovascular Therapy
Background: Earlier treatment and resolution for patients with cerebral aneurysms is now possible due to earlier diagnosis. This observational study aims to evaluate the intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing endovascular therapy.
Method: This is an observational prospective study. Patients ≥ 18 years old diagnosed with an unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt \& Hess grade I or II) undergoing endovascular treatment under general anesthesia between April 2015 and February 2017 were included. Non-invasive measurements of hemodynamic variables were collected at six time points during the procedure (T1 to T6). Statistical analysis was performed by using central tendency measures for quantitative variables and absolute / relative frequency measurements for qualitative variables.
Read the detailed description
Objective
- To assess the usefulness of general anesthesia with Laryngeal Mask Airway (LMA)-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis Data collection Anesthetic protocol was standardized for all patients consisting of an intravenous induction with fentanyl (1-2 μg/kg), lidocaine (1.5 mg/kg), propofol (2 mg/kg), and dexamethasone (8 mg) followed by the insertion of the LMA-Classic. Sevoflurane with a minimal alveolar concentration (MAC) between 0.9 and 1.1%, dipyrone (2 gr IV), and morphine (0.05 mg/kg IV) were used during maintenance. Tidal volume (VT) and respiratory rate (RR) were adjusted to 7 ml/Kg and 12-14 per minute respectively. Non-invasive hemodynamic monitoring included mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and end-tidal carbon dioxide (ETCO2).
Data was collected within six time points: Time point 1: before induction, Time point 2: after induction, Time point 3: after LMA-Classic insertion, Time point 4: during the endovascular procedure, Time point 5: during coiling, and Time point 6: at the end of the procedure and LMA-Classic removal.
The following demographic and clinical data were collected: age, gender, American Society of Anesthesiologists Physical Status (ASA-PS), total procedure time, comorbidities, aneurysm location, and associated clinical manifestations. Adverse events, such as intraoperative aneurysm rupture or need for endotracheal intubation, will be recorded.
Ethical considerations Approvals were obtained from the ethics committees at Antioquia University and Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic. Patients signed an informed consent and confidentiality agreement before participating.
Statistical analysis Data was collected in an excel spreadsheet (Microsoft Excel 2010®), SAS 9.4 (SAS Institute, Cary, N.C.) was used for subsequent analysis. Continuous variables were summarized as means and standard deviations (SD). Categorical variables were summarized as frequencies and percentages. Linear mixed models were fit to model continuous clinical variables over time using contrasts to test differences between time points. P-values less than 0.05 were considered to be statistically significant.
- Conditions
- Cerebral Aneurysm Unruptured, Cerebral Aneurysm, Hemodynamic Instability, Airway Morbidity
- Keywords
- Cerebral aneurysm, Endovascular therapy, Classic laryngeal mask airway, Hemodynamic changes
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure)
- To assess the usefulness of general anesthesia with LMA-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis
Measured: Outcome measure will be assessed from baseline (defined as time point 1, before induction) until the end of the surgery and laryngeal mask removal (defined as time point 6). Data will be reported within one year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Apr 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral Aneurysm UnrupturedStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco J Gomez Oquendo, MD, Principal investigator, Department of Anesthesiology, University of Antioquia, Medellin, Colombia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288519
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be shared with our colleagues at The Ohio State University for posterior data analysis
Publications
Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.
PubMed 24646873Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
PubMed 16943405Weir B, Disney L, Karrison T. Sizes of ruptured and unruptured aneurysms in relation to their sites and the ages of patients. J Neurosurg. 2002 Jan;96(1):64-70. doi: 10.3171/jns.2002.96.1.0064.
PubMed 11794606Chowdhury T, Cappellani RB, Sandu N, Schaller B, Daya J. Perioperative variables contributing to the rupture of intracranial aneurysm: an update. ScientificWorldJournal. 2013 Nov 12;2013:396404. doi: 10.1155/2013/396404.
PubMed 24324371Lee CZ, Young WL. Anesthesia for endovascular neurosurgery and interventional neuroradiology. Anesthesiol Clin. 2012 Jun;30(2):127-47. doi: 10.1016/j.anclin.2012.05.009. Epub 2012 Jul 13.
PubMed 22901603Kundra S, Mahendru V, Gupta V, Choudhary AK. Principles of neuroanesthesia in aneurysmal subarachnoid hemorrhage. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):328-37. doi: 10.4103/0970-9185.137261.
PubMed 25190938
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Classic Laryngeal Mask Airway in Patients With Cerebral Aneurysm Undergoing Endovascular Therapy
- ClinicalTrials.gov ID
- NCT03288519
- Acronym / sponsor ID
- 001
- Conditions
- Cerebral Aneurysm Unruptured, Cerebral Aneurysm, Hemodynamic Instability, Airway Morbidity
- Keywords
- Cerebral aneurysm, Endovascular therapy, Classic laryngeal mask airway, Hemodynamic changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 20 Sep 2017 (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.
Background: Earlier treatment and resolution for patients with cerebral aneurysms is now possible due to earlier diagnosis. This observational study aims to evaluate the intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing endovascular therapy.
Method: This is an observational prospective study. Patients ≥ 18 years old diagnosed with an unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt \& Hess grade I or II) undergoing endovascular treatment under general anesthesia between April 2015 and February 2017 were included. Non-invasive measurements of hemodynamic variables were collected at six time points during the procedure (T1 to T6). Statistical analysis was performed by using central tendency measures for quantitative variables and absolute / relative frequency measurements for qualitative variables.
Detailed description
Objective
- To assess the usefulness of general anesthesia with Laryngeal Mask Airway (LMA)-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis Data collection Anesthetic protocol was standardized for all patients consisting of an intravenous induction with fentanyl (1-2 μg/kg), lidocaine (1.5 mg/kg), propofol (2 mg/kg), and dexamethasone (8 mg) followed by the insertion of the LMA-Classic. Sevoflurane with a minimal alveolar concentration (MAC) between 0.9 and 1.1%, dipyrone (2 gr IV), and morphine (0.05 mg/kg IV) were used during maintenance. Tidal volume (VT) and respiratory rate (RR) were adjusted to 7 ml/Kg and 12-14 per minute respectively. Non-invasive hemodynamic monitoring included mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and end-tidal carbon dioxide (ETCO2).
Data was collected within six time points: Time point 1: before induction, Time point 2: after induction, Time point 3: after LMA-Classic insertion, Time point 4: during the endovascular procedure, Time point 5: during coiling, and Time point 6: at the end of the procedure and LMA-Classic removal.
The following demographic and clinical data were collected: age, gender, American Society of Anesthesiologists Physical Status (ASA-PS), total procedure time, comorbidities, aneurysm location, and associated clinical manifestations. Adverse events, such as intraoperative aneurysm rupture or need for endotracheal intubation, will be recorded.
Ethical considerations Approvals were obtained from the ethics committees at Antioquia University and Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic. Patients signed an informed consent and confidentiality agreement before participating.
Statistical analysis Data was collected in an excel spreadsheet (Microsoft Excel 2010®), SAS 9.4 (SAS Institute, Cary, N.C.) was used for subsequent analysis. Continuous variables were summarized as means and standard deviations (SD). Categorical variables were summarized as frequencies and percentages. Linear mixed models were fit to model continuous clinical variables over time using contrasts to test differences between time points. P-values less than 0.05 were considered to be statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An observational prospective study was undertaken in the Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic in Bello, Antioquia, Colombia. The investigators included patients ≥ 18 years old diagnosed with an unruptured cerebral aneurysm or SAH (Hunt \& Hess grade I or II) undergoing endovascular treatment under general anesthesia between April 2015 and February 2017. The investigators excluded patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and patients with SAH (Hunt \& Hess grade > II).
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old
- Diagnosed with an unruptured cerebral aneurysm or SAH (Hunt \& Hess grade I or II)
- Planned to undergo endovascular therapy under general anesthesia between April 2015 and February 2017 in the Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic in Bello, Antioquia, Colombia
Key exclusion criteria (1 listed)
- Patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and patients with SAH (Hunt \& Hess grade > II).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure)
Time frame: Outcome measure will be assessed from baseline (defined as time point 1, before induction) until the end of the surgery and laryngeal mask removal (defined as time point 6). Data will be reported within one year after study completion
• To assess the usefulness of general anesthesia with LMA-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis
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 19 Dec 2018.
- Background: PubMed 24646873Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.
- Background: PubMed 16943405Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
- Background: PubMed 11794606Weir B, Disney L, Karrison T. Sizes of ruptured and unruptured aneurysms in relation to their sites and the ages of patients. J Neurosurg. 2002 Jan;96(1):64-70. doi: 10.3171/jns.2002.96.1.0064.
- Background: PubMed 24324371Chowdhury T, Cappellani RB, Sandu N, Schaller B, Daya J. Perioperative variables contributing to the rupture of intracranial aneurysm: an update. ScientificWorldJournal. 2013 Nov 12;2013:396404. doi: 10.1155/2013/396404.
- Results publication: PubMed 22901603Lee CZ, Young WL. Anesthesia for endovascular neurosurgery and interventional neuroradiology. Anesthesiol Clin. 2012 Jun;30(2):127-47. doi: 10.1016/j.anclin.2012.05.009. Epub 2012 Jul 13.
- Results publication: PubMed 25190938Kundra S, Mahendru V, Gupta V, Choudhary AK. Principles of neuroanesthesia in aneurysmal subarachnoid hemorrhage. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):328-37. doi: 10.4103/0970-9185.137261.
- Individual participant dataSharing planned: No. De-identified data will be shared with our colleagues at The Ohio State University for posterior data analysis
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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.
Francisco J Gomez Oquendo, MD principal investigator
Department of Anesthesiology, University of Antioquia, Medellin, Colombia.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aneurysm Unruptured and Cerebral Aneurysm, run by Universidad de Antioquia.
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 3 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure) (time frame: Outcome measure will be assessed from baseline (defined as time point 1, before induction) until the end of the surgery and laryngeal mask removal (defined as time point 6). Data will be reported within one year after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288519, which also lists 6 linked publications.
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 19 Dec 2018.