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Trial registered on ANZCTR


Registration number
ACTRN12614000032651
Ethics application status
Approved
Date submitted
19/12/2013
Date registered
10/01/2014
Date last updated
10/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the AMBU Aura-i and LMA Supreme supraglottic airway devices in spontaneously breathing anaesthetised patients
Scientific title
A study comparing the clinical performance and insertion parameters of the AMBU Aura-i and LMA Supreme supraglottic airway devices in spontaneously breathing anaesthetised females undergoing minor gynaeocological procedures.
Secondary ID [1] 283809 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Performance of airway device 290787 0
Spontaneously breathing anaesthetised females undergoing minor gynaeocological procedures 290868 0
Condition category
Condition code
Anaesthesiology 291155 291155 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After induction of a standard general anaesthetic, the supraglottic airway (Ambu aura-i) was inserted into the patient's mouth and insertion parameters recorded. The amount of the air needed to inflate the cuff was measured.

The duration required to insert the airway device will be timed from when the device enters the patient's mouth till the appearance of the first square end-tidal carbon dioxide (ETCO2) trace, therefore denoting successful establishment of effective ventilation.

Insertion parameters to be recorded are the device's ease of insertion, number of insertion attempts, oropharyngeal leak pressure, fibreoptic position, and haemodynamic response. These were recorded by an unblinded observer who was not involved in the study.
Intervention code [1] 288495 0
Treatment: Devices
Comparator / control treatment
In the comparator group, participants will be inserted with the LMA Supreme airway device. The procedure of insertion is the same as for the intervention group. The amount of the air needed to inflate the cuff was measured. The duration required to insert the airway device will be timed from the when the device enters the patient's mouth till the appearance of the first square end-tidal carbon dioxide (ETCO2) trace, therefore denoting successful establishment of effective ventilation. Insertion parameters to be recorded are the device's ease of insertion, number of insertion attempts, oropharyngeal leak pressure, fibreoptic position, and haemodynamic response. These were recorded by an unblinded observer who was not involved in the study.
Control group
Active

Outcomes
Primary outcome [1] 291140 0
The time taken to establish effective ventilation.This is the interval from when the Ambu Aura-i or LMA Supreme entered the mouth to the first capnograph trace.
Timepoint [1] 291140 0
After the Ambu Aura-i or LMA Supreme airway device has been inserted into the participant's mouth.
Secondary outcome [1] 306115 0
Ease of insertion of airway device assessed at point of airway device insertion on a 5 point scale (1= easy, 2 = not so easy, 3 = difficult, 4= very difficult, 5= impossible.)
Timepoint [1] 306115 0
At point of of airway device insertion during procedure.
Secondary outcome [2] 306261 0
Oropharyngeal leak pressure (OLP)- as measured by closing the adjustable pressure limiting (APL) valve with a fresh gas flow of 3 L min-1, noting the airway pressure at equilibrium on manometer or when there was an audible air leak from the throat.
Timepoint [2] 306261 0
OLP assessed after airway device inserted into participant's mouth.
Secondary outcome [3] 306262 0
The fiberoptic view of the glottis; scored as follows: 0 = failure to function with no vocal cords (VC) seen, 1 = VC not seen but function adequate, 2= VC plus anterior epiglottis seen, 3= VC plus posterior epiglottis seen, 4 = only VC seen.
Timepoint [3] 306262 0
Fibreoptic view assessed after insertion of airway device into participant's mouth.
Secondary outcome [4] 306263 0
Haemodynamic response eg.Blood pressure and heart rate as measured every minute for the first five minutes from induction of anaesthesia.
Timepoint [4] 306263 0
Blood pressure and heart rate as measured every minute for the first five minutes from induction of anaesthesia.
Secondary outcome [5] 306264 0
Presence of visible blood on device.
Timepoint [5] 306264 0
The airway device is inspected for presence of visible blood upon its removal from participant's mouth at the end of srgery.
Secondary outcome [6] 306265 0
Post-operative sore throat ( by direct questioning of participants)
Timepoint [6] 306265 0
Assessed in the PACU (post anaesthesia care unit) forty- five minutes after surgery by an independent observer.
Secondary outcome [7] 306266 0
Dysphonia (by direct questioning of participants)
Timepoint [7] 306266 0
Assessed in the PACU (post anaesthesia care unit) forty- five minutes after surgery by an independent observer.
Secondary outcome [8] 306267 0
Dysphagia (by direct questioning of participants)
Timepoint [8] 306267 0
Assessed in the PACU (post anaesthesia care unit) forty- five minutes after surgery by an independent observer.

Eligibility
Key inclusion criteria
One hundred ASA I- II patients scheduled for elective minor gynaecological and breast procedures in our women's hospital
Minimum age
21 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA physical status III or IV; BMI equal to and greater than 40 kg/m2, those with predicted difficult airway; high risk of regurgitation or aspiration; and respiratory tract pathology (including preoperative sore throat).

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)
Eligible participants were interviewed and invited to participate. Sealed, opaque envelopes concealed the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome tested was time to LMA insertion. Sample size was based on earlier studies of AMBU LMA insertion in non-paralysed, anaesthetized patients . Prospective power analysis showed that a sample size of 50 patients per group would be required to detect a 30% difference in the primary outcome at a significance level of 5% and power of 80%.

The following tests were used to compare the data between the two groups: Student’s t-test for parametric data, patient demographics and time to insertion; Mann-Whitney U-test for Mallampati grading, ease of insertion, number of attempts; chi – square / Fisher’s exact test for comparison of proportions. All statistical analyses was performed using SPSS 16.0 (IBM) software. A p value of less than or equal to 0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2012
Actual
10/05/2012
Date of last participant enrolment
Anticipated
31/12/2012
Actual
14/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5695 0
Singapore
State/province [1] 5695 0

Funding & Sponsors
Funding source category [1] 288469 0
Self funded/Unfunded
Name [1] 288469 0
Country [1] 288469 0
Primary sponsor type
Individual
Name
Dr Wendy H.L. Teoh
Address
KK Women’s and Children’s Hospital,
100 Bukit Timah Road, Singapore 229899.
Country
Singapore
Secondary sponsor category [1] 287171 0
None
Name [1] 287171 0
Address [1] 287171 0
Country [1] 287171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290336 0
Singhealth Centralised Institutional Review Board D
Ethics committee address [1] 290336 0
Ethics committee country [1] 290336 0
Singapore
Date submitted for ethics approval [1] 290336 0
28/03/2012
Approval date [1] 290336 0
10/05/2012
Ethics approval number [1] 290336 0
CIRB 2012-256-D

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45142 0
Dr Wendy H.L. Teoh
Address 45142 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country 45142 0
Singapore
Phone 45142 0
+65- 63941081
Fax 45142 0
+65- 62912661
Email 45142 0
[email protected]
Contact person for public queries
Name 45143 0
Wendy H.L. Teoh
Address 45143 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country 45143 0
Singapore
Phone 45143 0
+65- 63941081
Fax 45143 0
Email 45143 0
[email protected]
Contact person for scientific queries
Name 45144 0
Wendy H.L. Teoh
Address 45144 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country 45144 0
Singapore
Phone 45144 0
+65- 63941081
Fax 45144 0
Email 45144 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
EmbaseThe AMBU Aura-iTM Laryngeal Mask and LMA SupremeTM: A Randomized Trial of Clinical Performance and Fibreoptic Positioning in Unparalysed, Anaesthetised Patients by Novices.2016https://dx.doi.org/10.1155/2016/4717061
N.B. These documents automatically identified may not have been verified by the study sponsor.