Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000300572
Ethics application status
Not yet submitted
Date submitted
13/03/2015
Date registered
31/03/2015
Date last updated
31/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing fibreoptic-guided tracheal intubation using two supraglottic devices: Ambu AuraGain Laryngeal Mask Airway 'Registered Trademark' and LMA Fastrach 'Registered Trademark'
Scientific title
A randomized controlled trial in adults undergoing surgery, to compare the speed and efficacy of fibreoptic-guided tracheal intubation through two supraglottic devices: Ambu AuraGain LMA 'Registered Trademark' and LMA Fastrach 'Registered Trademark'
Secondary ID [1] 286354 0
Nil
Universal Trial Number (UTN)
U111111682489
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
difficult airway intubation 294485 0
Condition category
Condition code
Anaesthesiology 294789 294789 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ambu AuraGain LMA 'Registered Trademark'. The Ambu AuraGain will be inserted and after achieving satisfactory ventilation via the supraglottic airway device, fibreopitc-guided tracheal intubation will then commence. A maximum of 2 attempts at intubation will be given. The intubation will be performed by an experienced anaesthetist (>10 years’ since commencement of specialist training) who is familiar with the use of both devices (>10 uses on each device) prior to the study. Assessment of any complications will occur directly post-operatively in recovery by the anaesthetist performing the intubation.
Intervention code [1] 291416 0
Treatment: Devices
Comparator / control treatment
LMA Fastrach 'Registered Trademark'. The LMA Fastrach will be inserted and after achieving satisfactory ventilation via the supraglottic airway device, fibreopitc-guided tracheal intubation will then commence. A maximum of 2 attempts at intubation will be given. The intubation will be performed by an experienced anaesthetist (>10 years’ since commencement of specialist training) who is familiar with the use of both devices (>10 uses on each device) prior to the study. Assessment of any complications will occur directly post-operatively in recovery by the anaesthetist performing the intubation.
Control group
Active

Outcomes
Primary outcome [1] 294542 0
Comparison of fibreoptic scores which evaluate the laryngeal alignment according to the standardized scale proposed by Brimacombe
Timepoint [1] 294542 0
Time of intubation
Secondary outcome [1] 313588 0
Time needed to insert the supraglottic device (SAD)
Timepoint [1] 313588 0
At the time of insertion of the supraglottic device (SAD)
Secondary outcome [2] 313589 0
Time taken for endotracheal intubation
Timepoint [2] 313589 0
At the time of intubation
Secondary outcome [3] 313590 0
Number of insertion attempts with the allocated SAD (a failed insertion attempt is defined as complete withdrawal of the device from the mouth following an unsuccessful placement).
Timepoint [3] 313590 0
Time of insertion of SAD
Secondary outcome [4] 313591 0
Number of fibreoptic-guided intubation attempts (a failed intubation is defined as complete withdrawal of the fibreoptic scope from the patient following unsuccessful placement).
Timepoint [4] 313591 0
Time of intubation
Secondary outcome [5] 313592 0
Any complications associated with the intubation will be recorded, such as, injury to lips, oral mucosal and dentition, hypoxia (SpO2 < 90%) during intubation, sore throat, dysphagia and dysphonia
Timepoint [5] 313592 0
conclusion of procedure

Eligibility
Key inclusion criteria
ASA I, II or III and > 18 years of age, who are scheduled for surgery requiring oro-tracheal intubation at the Royal Melbourne Hospital will be recruited for this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are non-English speaking, require an awake fibreoptic intubation, have a known laryngeal pathology or with contra-indications to the use of supraglottic airway device (weight >100 kg, interincisor distance <2.5cm, or aspiration risk) are not included

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3564 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 290926 0
Hospital
Name [1] 290926 0
Royal Melbourne Hospital
Country [1] 290926 0
Australia
Primary sponsor type
Individual
Name
Elizabeth Judson
Address
Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria
3050
Country
Australia
Secondary sponsor category [1] 289612 0
None
Name [1] 289612 0
Address [1] 289612 0
Country [1] 289612 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292532 0
HREC RMH
Ethics committee address [1] 292532 0
Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria
3050
Ethics committee country [1] 292532 0
Australia
Date submitted for ethics approval [1] 292532 0
26/03/2015
Approval date [1] 292532 0
Ethics approval number [1] 292532 0

Summary
Brief summary
To compare fibroptic guided intubation through two supraglottic devices. This is helpful in the management of patients with difficult airways where conventional intubation is unable to be achieved
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55778 0
Dr Elizabeth Judson
Address 55778 0
Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria
3050
Country 55778 0
Australia
Phone 55778 0
+61 03 93427000
Fax 55778 0
Email 55778 0
[email protected]
Contact person for public queries
Name 55779 0
Elizabeth Judson
Address 55779 0
Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria
3050
Country 55779 0
Australia
Phone 55779 0
+61 03 93427000
Fax 55779 0
+61 03 93427000
Email 55779 0
[email protected]
Contact person for scientific queries
Name 55780 0
Reny Segal
Address 55780 0
Royal Melbourne Hospital
300 Grattan St
Parkville
Victoria
3050
Country 55780 0
Australia
Phone 55780 0
+61 03 93427000
Fax 55780 0
Email 55780 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA Randomised Controlled Trial Comparing Fibreoptic-Guided Tracheal Intubation through Two Supraglottic Devices: Ambu AuragainTM Laryngeal Mask and LMA FastrachTM.2018https://dx.doi.org/10.1177/0310057X1804600508
N.B. These documents automatically identified may not have been verified by the study sponsor.