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Trial registered on ANZCTR


Registration number
ACTRN12618000509268
Ethics application status
Approved
Date submitted
16/08/2017
Date registered
9/04/2018
Date last updated
9/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laryngeal Mask Airway versus Tracheal Tube for Endovascular Treatment
Scientific title
Laryngeal Mask Airway versus Tracheal Tube for Endovascular Treatment of Unruptured Cerebral Aneurysms: A Randomized Trial Of Safety And Efficacy
Secondary ID [1] 292664 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unruptured cerebrovascular aneurysms 304404 0
hypertension 304405 0
Condition category
Condition code
Anaesthesiology 303733 303733 0 0
Anaesthetics
Neurological 303735 303735 0 0
Other neurological disorders
Cardiovascular 303835 303835 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing Endovascular treatment (EVT) for unruptured cerebrovascular aneurysms were randomized to secure the airway with a laryngeal mask airway (LMA, a supraglottic airway device which is frequently used to secure airway for general anesthesia, and also as an alternative to tracheal tube for difficult airway interventions) or tracheal tube (TT). LMA is placed after the induction of general anesthesia, and removed at the end of the procedure, which means after the surgery and/ or intervention is completed, anesthesia is discontinued and the patient is awaked, the same conditions for TT. Anesthesia was induced with propofol and fentanyl and maintained with remifentanil/propofol-based intravenous anesthesia. Rocuronium ( a nondepolarizing neuromuscular blocker, 0.6 mg/kg intravenously, after the induction of general anesthesia, additional doses were not given) was used in group TT to facilitate tracheal intubation. Hemodynamic parameters were measured before and after airway management and throughout the procedure. After the procedure, recovery times were measured. Respiratory events were recorded.
Intervention code [1] 298902 0
Treatment: Devices
Comparator / control treatment
TT is placed by an anaesthesiologist in the trachea using a laryngoscope ( tracheal intubation) in the TTgroup (control group) . The device remains in place until the end of the anaesthesia. The device is removed after the completion of radiological intervention and anesthesia when the extubation criteria have fulfilled.
Control group
Active

Outcomes
Primary outcome [1] 303106 0
Td ( time to discharge) from both groups are compared.
Timepoint [1] 303106 0
Td ( time to discharge) means the duration between the end of anesthesia and to be ready for discharge from angiography unit
Secondary outcome [1] 337896 0
Vital parameters (Heart rate as measured by ECG, Peripheral oxygen saturation as measured by pulseoxymetry are composite secondary outcome.
Timepoint [1] 337896 0
before induction (baseline), before (preintubation) and after tracheal intubation or LMA insertion (postintubation), after extubation or removal of the LMA (postextubation), and at 5-min intervals during the procedure.
Secondary outcome [2] 338216 0
Respiratory events ( gagging, laryngospasm, cough etc) are secondary outcomes. These respiratory events were assessed clinically.
This is a composite outcome.
Timepoint [2] 338216 0
Preinduction
After induction
Before intubation
After intubation
After extubation
Secondary outcome [3] 344135 0
Noninvasive blood pressure as measured by sphygmomanometer
Timepoint [3] 344135 0
Td ( time to discharge) means the duration between the end of anesthesia and to be ready for discharge from angiography unit

Eligibility
Key inclusion criteria
American Society of Anthesiologists grades I–III patients who were scheduled to undergo elective endovascular embolization of unruptured intracranial aneurysms were included in the study
Minimum age
16 Years
Maximum age
67 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients in whom a difficult airway was anticipated (e.g., Mallampati score IV, limited mouth opening, history of difficult intubation), who were at increased risk of regurgitation (gastric reflux, hiatal hernia, body mass index > 40 kg m-2), who had asthma or known allergies to the study’s medications, who were pregnant, or who had a Glasgow Coma Scale (GCS) score of <15 upon neurological examination were excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9150 0
Turkey
State/province [1] 9150 0
ankara

Funding & Sponsors
Funding source category [1] 297299 0
Hospital
Name [1] 297299 0
29 May Diyanet Foundation Hospital
Address [1] 297299 0
Dikmen Street 312 Cankaya/Ankara
Postcode 06105
Country [1] 297299 0
Turkey
Primary sponsor type
Hospital
Name
29 May Diyanet Foundation Hospital
Address
Dikmen Street 312 Cankaya/Ankara
Postcode 06105
Country
Turkey
Secondary sponsor category [1] 296271 0
None
Name [1] 296271 0
Address [1] 296271 0
Country [1] 296271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298407 0
Ethics Committee of TDV 29 Mayis Hospital
Ethics committee address [1] 298407 0
Dikmen cad 312 çankaya Ankara
Postcode 06105
Ethics committee country [1] 298407 0
Turkey
Date submitted for ethics approval [1] 298407 0
Approval date [1] 298407 0
12/04/2010
Ethics approval number [1] 298407 0
042010/17

Summary
Brief summary
When reviewing the literature, it is noteworthy that tracheal intubation with neuromuscular blocking agents has been generally proposed to secure the airway for controlled ventilation, as in neurosurgery. It is also well known that tracheal intubation and direct laryngoscopy have harmful effects on hemodynamic parameters during intubation and extubation periods that may cause ICP elevation and a ruptured aneurysm. There are few prospective, randomized studies that have investigated the availability of supraglottic airway devices in the EVT setting. Only one report indicated that LMA was safely used in three patients undergoing EVT of unruptured cerebral aneurysms .
In this prospective, randomized study, we aimed to test the hypothesis that the use of a laryngeal mask airway (LMA) versus a tracheal tube (TT) could result in a lower incidence of hemodynamic changes, decrease the number of respiratory events, and secure the airway as well as the TT in patients undergoing EVT for a cerebrovascular aneurysm
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 76990 0
Dr CEYDA OZHAN CAPARLAR
Address 76990 0
University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Sehit Omer Halisdemir str. No:1 Postcode: 06110 Altindag/ANKARA
Country 76990 0
Turkey
Phone 76990 0
+903125962553
Fax 76990 0
Email 76990 0
mdceydacaparlar@yahoo.com
Contact person for public queries
Name 76991 0
Dr CEYDA OZHAN CAPARLAR
Address 76991 0
University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Sehit Omer Halisdemir str. No:1 Postcode: 06110 Altindag/ANKARA
Country 76991 0
Turkey
Phone 76991 0
+903125962553
Fax 76991 0
Email 76991 0
mdceydacaparlar@yahoo.com
Contact person for scientific queries
Name 76992 0
Dr CEYDA OZHAN CAPARLAR
Address 76992 0
University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Sehit Omer Halisdemir str. No:1 Altindag/ANKARA Postcode : 06110
Country 76992 0
Turkey
Phone 76992 0
+903125962553
Fax 76992 0
Email 76992 0
mdceydacaparlar@yahoo.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary