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Trial registered on ANZCTR


Registration number
ACTRN12614001290684
Ethics application status
Approved
Date submitted
27/10/2014
Date registered
10/12/2014
Date last updated
10/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ambu AuraGain versus LMA Supreme Second Seal:
oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients
Scientific title
Ambu AuraGain versus LMA Supreme Second Seal: comparing
oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients under general anaesthesia
Secondary ID [1] 285485 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supraglottic device use in spontaneously breathing patients under general anaesthesia 293271 0
Condition category
Condition code
Anaesthesiology 293537 293537 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of Ambu Auragain supraglottic device by an experienced anaesthesiologist (>10 year working experience).

The Ambu Auragain differs from the LMA Supreme (control device) in which it has the added feature of intubation capability.
After the placement of the Ambu Auragain, it can be used as a conduit for direct endotracheal intubation assisted by a flexible scope.


Patient is not premedicated. He/she will be positioned supine, and pre-oxygenated for 3 minutes.
Standardised induction of anaesthesia with intravenous fentanyl 1-2 mcg/kg and propofol 2-3mg/kg.
Ambu Auragain will be inserted when the patient's jaw is sufficiently slack.
The duration of an insertion attempt is no longer than 120 seconds.
The appearance of the first square end-tidal CO2 trace denotes successful establishment of effective ventilation.
Otherwise, the device will be completely removed for another insertion attempt. (up to 3 attempts allowed)

Once in place, the Ambu Auragain will be secured with surgical tape.
A prelubricated 14 French gauge gastric tube will then be inserted into the gastric drain outlet, and ease & time taken for insertion will be assessed.
Gastric decompression will be done and total amount of gastric fluid aspirated to be recorded.

Oropharyngeal leak pressure will be measured after closing the adjustable pressure limiting valve with a fresh gas flow of 3 L/min, noting the airway pressure at equilibrium or when there is audible air leak from the throat.
Maximum pressure allowed is 40 cm H2O.

The patient's heart rate and blood pressure will be recorded every minute for the first 5 minutes from induction of anaesthesia.
Anaesthesia will be maintained with sevoflurane 1-2 MAC.

Upon end of the surgery, the Ambu Auragain will be removed (upon return of spontaneous breathing & eye opening)

45 minutes later, a blinded, independent observer will assess the patient for post operative sore throat, dysphonia and dysphagia.
Intervention code [1] 290425 0
Treatment: Devices
Comparator / control treatment
The Laryngeal Mask Airway Supreme (Second Seal) will be used for the control group (50 separate subjects). Induction of anaesthesia, checking of oropharyngeal leak pressure, gastric drain functionality and other complications will be exactly the same as for the Intervention group (Ambu Auragain)
Control group
Active

Outcomes
Primary outcome [1] 293431 0
Measurement of oropharyngeal leak pressure (in cm H2O) of the satisfactorily placed supraglottic airway device, using a handheld aneroid manometer (Portex Pressure Gauge)
Timepoint [1] 293431 0
After insertion of supraglottic airway device
Primary outcome [2] 293432 0
Ease of insertion of gastric tube through the supraglottic airway device's gastric drain outlet.
Ease of insertion will be graded on a scale of 1 (easy), 2 (acceptable), 3 (difficult), and recorded in the data collection sheet.
Timepoint [2] 293432 0
After insertion of supraglottic airway device
Secondary outcome [1] 311034 0
Ease of supraglottic airway device insertion and number of attempts required.
Ease of insertion will be graded on a scale of 1 (easy), 2 (acceptable), 3 (difficult), and recorded in the data collection sheet.
Timepoint [1] 311034 0
During insertion of supraglottic airway device
Secondary outcome [2] 311035 0
Haemodynamic response to insertion of supraglottic airway device
(Systolic/diastolic/mean arterial blood pressure, heart rate)
-measured using automatic sphyngomanometer and ECG
Timepoint [2] 311035 0
From time of supraglottic airway device insertion, up to 5 minutes post insertion
Secondary outcome [3] 311036 0
Manouvres required to optimise ventilation after supraglottic airway device insertion:
-Head/neck position adjustment
-Change of depth of device insertion
-Application of jaw lift
-Change of device size
-Reinsertion of device
Timepoint [3] 311036 0
After insertion of supraglottic airway device
Secondary outcome [4] 311037 0
Complications of supraglottic airway device insertion, will be assessed by an unblinded independent observer who is not involved in this study.
Any complications noted will be recorded on the data collection sheet.
(Desaturation SpO2 < 95%, gross regurgitation/aspiration, tongue trauma, lip injury, difficulty in ventilation, bronchospasm, mucosal injury, post operative sore throat, dysphonia, dysphagia, dental injury)
Timepoint [4] 311037 0
From time of supraglottic airway device insertion up to 45 minutes after supraglottic device removal

Eligibility
Key inclusion criteria
Adult surgical patients above 18 years of age, undergoing surgery under general anaesthesia (appropriate to be done with a supraglottic airway device)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA IV;
morbidly obese BMI > 40kg/m2;
high risk or regurgitation/aspiration e.g.: symptomatic gastro-oesophageal reflux, hiatus hernia;
respiratory tract pathology e.g.: 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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Teoh WH, Anaes 2010 conducted a study involving LMA Supreme insertions that demonstrated a mean (SD) oropharyngeal leak pressure of 26 (5) cm H2O.
In order to detect a difference of 10%, prospective power analysis at 80% power and 0.05 level of significance (two tailed) showed that a sample size of 47 patients would be required.
Therefore, we recruited 50 patients per group to account for dropouts and protocol breaches.

Insertion times and other parametric data will be analyzed using the Student's t-test.
Mallampati scores and other non-parametric data will be analyzed using the Mann-Whitney U test.
Comparison of side effects will be analyzed using the Fisher'sw exact test.
Repeated measures of haemodynamic variables will be analyzed using the general linear model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/11/2014
Actual
11/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6407 0
Malaysia
State/province [1] 6407 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 290086 0
University
Name [1] 290086 0
Postgraduate Research Fund, Universiti Malaya
Country [1] 290086 0
Malaysia
Primary sponsor type
University
Name
Department of Anaesthesiology, Universiti Malaya
Address
Department of Anaesthesiology,
Universiti Malaya
50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 288785 0
None
Name [1] 288785 0
Address [1] 288785 0
Country [1] 288785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291862 0
University of Malaya Research Ethics (UMREC)
Ethics committee address [1] 291862 0
University of Malaya Medical Centre,
Lembah Pantai , 59100, Kuala Lumpur
Ethics committee country [1] 291862 0
Malaysia
Date submitted for ethics approval [1] 291862 0
06/08/2014
Approval date [1] 291862 0
24/09/2014
Ethics approval number [1] 291862 0
20148-425

Summary
Brief summary
The supraglottic airway device may substitute the invasive procedure of endotracheal intubation in selected patients/surgeries under general anaesthesia.

The Ambu AuraGain is a new phthalate-free, anatomically curved, single use supraglottic airway device launced in June 2014. It features an intergrated gastric access port.

We would like to compare the Ambu Auragain with the Lanyngeal Mask Airway Supreme (Second Seal), in terms of oropharyngeal leak pressure, ease of insertion, gastric drain functionality and haemodynamic response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52062 0
Dr Ina Ismiarti Shariffuddin
Address 52062 0
Department of Anaesthesiology,
Universiti Malaya,
50603 Kuala Lumpur
Country 52062 0
Malaysia
Phone 52062 0
+60379492052
Fax 52062 0
Email 52062 0
[email protected]
Contact person for public queries
Name 52063 0
Ina Ismiarti Shariffuddin
Address 52063 0
Department of Anaesthesiology,
Universiti Malaya,
50603 Kuala Lumpur
Country 52063 0
Malaysia
Phone 52063 0
+60379492052
Fax 52063 0
Email 52063 0
[email protected]
Contact person for scientific queries
Name 52064 0
Ina Ismiarti Shariffuddin
Address 52064 0
Department of Anaesthesiology,
Universiti Malaya,
50603 Kuala Lumpur
Country 52064 0
Malaysia
Phone 52064 0
+60379492052
Fax 52064 0
Email 52064 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
EmbaseAmbu AuraGainTM versus LMA SupremeTM Second SealTM: A randomised controlled trial comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients.2017https://dx.doi.org/10.1177/0310057x1704500215
N.B. These documents automatically identified may not have been verified by the study sponsor.