ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Unruptured cerebrovascular aneurysms

hypertension

Condition category

Condition code

Anaesthesiology

Anaesthetics

Neurological

Other neurological disorders

Cardiovascular

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]

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]

Td ( time to discharge) from both groups are compared.

Timepoint [1]

Td ( time to discharge) means the duration between the end of anesthesia and to be ready for discharge from angiography unit

Secondary outcome [1]

Vital parameters (Heart rate as measured by ECG, Peripheral oxygen saturation as measured by pulseoxymetry are composite secondary outcome.

Timepoint [1]

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]

Respiratory events ( gagging, laryngospasm, cough etc) are secondary outcomes. These respiratory events were assessed clinically.
This is a composite outcome.

Timepoint [2]

Preinduction
After induction
Before intubation
After intubation
After extubation

Secondary outcome [3]

Noninvasive blood pressure as measured by sphygmomanometer

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2010

Date of last participant enrolment

Anticipated

Actual

1/09/2014

Date of last data collection

Anticipated

Actual

1/09/2014

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

ankara

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

29 May Diyanet Foundation Hospital

Address [1]

Dikmen Street 312 Cankaya/Ankara
Postcode 06105

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of TDV 29 Mayis Hospital

Ethics committee address [1]

Dikmen cad 312 çankaya Ankara
Postcode 06105

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

12/04/2010

Ethics approval number [1]

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

Dr CEYDA OZHAN CAPARLAR

Address

University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Sehit Omer Halisdemir str. No:1 Postcode: 06110 Altindag/ANKARA

Country

Turkey

Phone

+903125962553

Fax

mdceydacaparlar@yahoo.com

Contact person for public queries

Name

CEYDA OZHAN CAPARLAR

Address

University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Sehit Omer Halisdemir str. No:1 Postcode: 06110 Altindag/ANKARA

Country

Turkey

Phone

+903125962553

Fax

mdceydacaparlar@yahoo.com

Contact person for scientific queries

Name

CEYDA OZHAN CAPARLAR

Address

University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Sehit Omer Halisdemir str. No:1 Altindag/ANKARA Postcode : 06110

Country

Turkey

Phone

+903125962553

Fax

mdceydacaparlar@yahoo.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Laryngeal mask airway for general anesthesia in interventional neuroradiology procedures.	2019	https://dx.doi.org/10.15537/smj.2019.5.24131

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically