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Trial registered on ANZCTR


Registration number
ACTRN12616000762459
Ethics application status
Approved
Date submitted
22/04/2016
Date registered
9/06/2016
Date last updated
26/10/2018
Date data sharing statement initially provided
26/10/2018
Date results information initially provided
26/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised comparison of AMBU (Registered Trademark) AuraGainTM & LMA Supreme TM in patients undergoing laparoscopic surgery under general anaesthesia.
Scientific title
A randomised comparison of AMBU(Registered Trademark) AuraGainTM & LMA Supreme TM in patients undergoing laparoscopic surgery under general anaesthesia.
Secondary ID [1] 288750 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
difficult airway 297994 0
Condition category
Condition code
Anaesthesiology 298150 298150 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the AMBU AuraGain laryngeal mask in patients undergoing laparoscopic surgery under general anaesthesia

The AMBU AuraGain laryngeal mask is a new phthalate-free, laryngeal mask device launched in June 2014. Both devices are similar in their fundamental design ie. anatomically curved airway tube, single-use disposable product, with a built-in gastric access port where an orogastric catheter can be inserted to suck out gastric contents and secretions, thereby enhancing patient safety when they undergo positive pressure ventilation. Laryngeal mask airways are inserted routinely for short surgeries as a means to maintain a patent airway to allow the patient to remain ventilated and oxygenated by an anaesthetic ventilator during surgery.

Insertion of device will be performed by 1 specialist anaesthetists (Principal Investigators) and 2 senior anaesthesia residents with at least 3 years experience, and at least 10 LMA Supreme & 10 AuraGain insertions in patients with normal airways before trial commencement; supervised by the Principal Investigator.

A maximum of 3 attempts at insertion of the laryngeal mask device is allowed.
Intervention code [1] 294184 0
Treatment: Devices
Comparator / control treatment
Use of the control device LMA Supreme in patients undergoing laparoscopic surgery under general anaesthesia

Laryngeal mask airways are inserted routinely for short surgeries as a means to maintain a patent airway to allow the patient to remain ventilated and oxygenated by an anaesthetic ventilator during surgery. The Supreme laryngeal mask (control device) is made of PVC and is similar to the AuraGain laryngeal mask (intervention device) in their fundamental design. The AuraGain has a further advantage of direct intubating capability, and may be suitable as a rescue device in a difficult airway situation. Inherent differences in materials may affect performance characteristics.

Control group
Active

Outcomes
Primary outcome [1] 297655 0
oropharyngeal leak pressure (OLP)
The oropharyngeal leak pressure is measured by closing the Adjustable Pressure Limiting valve of the circle system (of the anaesthesia machine) at a fixed gas flow of 3 L/min in manual ventilation mode. The oropharyngeal leak pressure is the pressure in the circuit when an audible noise was heard over the mouth. For safety concerns, the maximal allowable oropharyngeal leak pressure was 40cmH2O and auscultation over epigastrium is done at the same time to rule out air leak into stomach during measurement.
Timepoint [1] 297655 0
After succesful LMA insertion
Secondary outcome [1] 321717 0
Number of attempts at device insertion

Each attempt is defined as the re-insertion of the laryngeal mask device into the mouth.
Timepoint [1] 321717 0
During device insertion
Secondary outcome [2] 321718 0
Time to successful device placement

from insertion of airway device into mouth till presence of 1st end-tidal CO2 tracing on capnography
Timepoint [2] 321718 0
from insertion of airway device into mouth till presence of 1st end-tidal CO2 tracing on capnography
Secondary outcome [3] 321719 0
Subjective ease of device insertion on a 5 point scale

5 point scale: Easy, Fair, Difficult, Very Difficult, Impossible
Timepoint [3] 321719 0
During LMA insertion
Secondary outcome [4] 321720 0
Additional manoeuvres required for insertion
(adjustment of head and neck position, jaw thrust, change of device size, change of depth insertion) will be recorded in our data collection sheet
Timepoint [4] 321720 0
During LMA insertion
Secondary outcome [5] 321721 0
Ease of insertion of lubricated NG tube on a 3 point scale: easy, difficult, impossible
Timepoint [5] 321721 0
During NG tube insertion through the LMA device
Secondary outcome [6] 321722 0
Peak inspiratory pressure (PIP) as measured by the spirometry analyser in the anaesthesia machine
Timepoint [6] 321722 0
During the entire surgical procedure at fixed intervals, i.e. before pneumoperitoneum creation, after pneumoperitoneum creation and then at 30 minutes interval thereafter
Secondary outcome [7] 321723 0
Leak volume, defined as the difference between inspiratory and expiratory volume, as measured by the spirometry analyser in the anaesthesia machine
Timepoint [7] 321723 0
During the entire surgical procedure at fixed intervals, i.e. before pneumoperitoneum creation, after pneumoperitoneum creation and then at 30 minutes interval thereafter
Secondary outcome [8] 321724 0
Cuff pressure measured with a cuff pressure gauge (VBM Medizintechnik GmbH, Germany).
Timepoint [8] 321724 0
measured after device insertion, and then during the entire surgical procedure at fixed intervals i.e. before pneumoperitoneum creation, after pneumoperitoneum creation and then at 30 minutes interval thereafter
Secondary outcome [9] 321726 0
Intra-abdominal pressure as measured by the CO2 insufflation machine used by the surgical team for laparoscopic surgery. Ths machine measures and displays the intra-abdominal pressure achieved.
Timepoint [9] 321726 0
During the entire duration of pneumoperitoneum maintanence, measured at regular intervals, i.e. before pneumoperitoneum creation, after pneumoperitoneum creation and then at 30 minutes interval thereafter.
Secondary outcome [10] 321727 0
Intraoperative hemodynamic parameters of Heart rate as analysed by ECG module of the anaesthesia monitor
Timepoint [10] 321727 0
measured every minute from induction of general anaesthesia, up till 3 minutes after successful LMA placement.
Secondary outcome [11] 321728 0
intraoperative Complication of desaturation below 95% as analysed by the pulse oximetry of the anaesthesia monitor
Timepoint [11] 321728 0
measured during LMA insertion
Secondary outcome [12] 323792 0
non-invasive blood pressure monitoring as analysed by non-inviasve blood pressure module of the anaesthesia monitor
Timepoint [12] 323792 0
measured every minute from induction of general anaesthesia, up till 3 minutes after successful LMA placement.
Secondary outcome [13] 323793 0
oxygen saturation as measured by pulse oximetry
Timepoint [13] 323793 0
measured every minute from induction of general anaesthesia, up till 3 minutes after successful LMA placement.
Secondary outcome [14] 323794 0
intraoperative complication of bronchospasm as evident by upsloping of the capnography, high peak airway pressure and presence of rhonchi upon auscultation of lungs
Timepoint [14] 323794 0
measured during and immediately after LMA insertion
Secondary outcome [15] 323795 0
intraoperative complication of aspiration/gross regurgitation as evident by the presence of gastric fluid in the gastric and/or airway port of the laryngeal mask device
Timepoint [15] 323795 0
observed during LMA insertion and throughout surgical procedure
Secondary outcome [16] 323796 0
oral cavity injury upon visual inspection by anaesthesiologist.
Timepoint [16] 323796 0
measured after LMA insertion
Secondary outcome [17] 323797 0
intraoperative complication of gastric distension as reported by the surgeons during laparoscopy
Timepoint [17] 323797 0
during laparoscopic surgery
Secondary outcome [18] 323798 0
blood on laryngeal mask device after removal as evident by the presence of blood upon examining the device after removal, observed by the anaesthetists
Timepoint [18] 323798 0
measured after surgery and after removal of laryngeal mask device
Secondary outcome [19] 323799 0
postoperative sorethroat self-reported by patients when questioned by the nurses in the recovery unit
Timepoint [19] 323799 0
measured postop in recovery unit
Secondary outcome [20] 323800 0
postoperative dysphonia self-reported by patients when questioned by the nurses in the recovery unit
Timepoint [20] 323800 0
measured postop in recovery unit
Secondary outcome [21] 323801 0
postoperative dysphagia (difficulty in swallowing) self-reported by patients when questioned by the nurses in the recovery unit
Timepoint [21] 323801 0
measured postop in recovery unit

Eligibility
Key inclusion criteria
1. American Society of Anesthesiologists (ASA) physical status Class I-III
2. between age 21 to 80,
3. who require general anaesthesia for laparoscopic surgeries eg. cholecystectomy, inguinal herniorraphy..
Minimum age
21 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients of age less than 21 or more than 80 years old,
2. BMI more than 35 kg/m2 or body weight less than 30kg,
3. patients with a predicted difficult airway (based on history of difficult airway, inter-incisor distance less than 20mm, cervical spine pathology, modified Mallampati class 4, thyromental distance less than 60mm),
4. where laryngeal mask devices are contraindicated: high risk of regurgitation or aspiration (GERD, hiatus hernia), respiratory tract pathology e.g. restrictive lung disease/active upper respiratory tract infection,
5. patients who decline to participate in the study or are unable to give informed consent.

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)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Teoh WH et al (Anaesthesia 2010) demonstrated that the mean oropharyngeal leak pressure with LMA Supreme was 26 +/- 5 cm H2O.
A difference of 10% in mean OLP between AG & LS is likely to be clinically relevant. Using a desired power of 80% and two-sided significance level of 5%, a sample size of 59 patients in each group (total of 118 patients) is estimated to be adequate for each supraglottic device(Stata v13.1). We will therefore recruit 60 per group to account for drop-outs.

Continuous variables will be presented as mean (standard deviation) or median (interquartile range) after assessing normality. Categorical variables will be summarised using frequency (percentage). Depending on the normality of continuous outcome variables, independent student’s t-test or Mann-Whitney U test will be conducted to compare means or medians between two groups. The chi-square test or Fisher’s exact test will be used for comparison of categorical variables when appropriate. General linear model for repeated measures will be used for analysis of hemodynamic variables.

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] 7702 0
Singapore
State/province [1] 7702 0
Singapore

Funding & Sponsors
Funding source category [1] 293439 0
Hospital
Name [1] 293439 0
Tan Tock Seng Hospital
Address [1] 293439 0
11 Jalan Tan Tock Seng
Singapore 308433
Country [1] 293439 0
Singapore
Primary sponsor type
Hospital
Name
Tan Tock Seng Hospital
Address
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng
Singapore 308433
Country
Singapore
Secondary sponsor category [1] 292262 0
None
Name [1] 292262 0
Address [1] 292262 0
Country [1] 292262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294885 0
Domain Specific Review Board
Ethics committee address [1] 294885 0
Domain Specific Review Board (DSRB)
c/o National Healthcare Group, Research & Development Office (RDO)
Nexus @One-North (South Tower), No. 3 Fusionopolis Link, #03-08, Singapore 138543
Ethics committee country [1] 294885 0
Singapore
Date submitted for ethics approval [1] 294885 0
28/07/2015
Approval date [1] 294885 0
02/06/2016
Ethics approval number [1] 294885 0
2015/00989

Summary
Brief summary
Supraglottic airway devices are useful in situations where the expected time of surgery & general anaesthesia is short & are effective yet easy to insert. The AuraGain resembles the LMA Supreme in terms of anatomical curvature & availability of gastric access; and also allows passage of a tracheal tube which is not possible in a LMA Supreme, thus increasing its utility as a disposable supraglottic device with added functionality. The AMBU AuraGain may be useful as an alternative to the LMA Supreme as a disposable supraglottic device, and coupled with its intubating capability, may be suitable as a rescue device in a difficult airway situation. The study's null hypothesis is the the AuraGain is as efficacious and the LMA Supreme in paralysed patients receiving controlled ventilation. We aim to recruit and randomise 118 patients between 21-80 years old, of ASA status I to III to receive either the AuraGain or the LMA Supreme during general anaesthesia with controlled ventilation for laparoscopic procedures. The primary outcome of the study is oropharyngeal leak pressure, and secondary outcomes include success of device insertion, time to successful device placement, leak volume, peak inspiratory pressure and complications. Risks to participants are related that of general anaesthesia and LMA insertion, such as dental trauma, post-operative nausea and vomiting and sorethroat. Such side effects are very mild in severity and of short duration (less than 1 day). Rare adverse effects include regurgitation and aspiration. Upon completion, the study investigators can better advise local institutions if the AMBU AuraGain can be considered as an alternative airway device, especially for controlled ventilation. If the AuraGain (AMBU, Singapore) is shown to be similar or better in efficacy over the LMA Supreme, it may be useful as an alternative to the LMA Supreme in laparoscopic surgeries, with the added advantage of use as a rescue device in a difficult airway situation allowing direct intubation through the AuraGain via a flexible scope
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64342 0
Dr Zhang Jinbin
Address 64342 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng
Singapore 308433
Country 64342 0
Singapore
Phone 64342 0
+6596542881
Fax 64342 0
Email 64342 0
jinbin_zhang@ttsh.com.sg
Contact person for public queries
Name 64343 0
Dr Zhang Jinbin
Address 64343 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng
Singapore 308433
Country 64343 0
Singapore
Phone 64343 0
+6596542881
Fax 64343 0
Email 64343 0
jinbin_zhang@ttsh.com.sg
Contact person for scientific queries
Name 64344 0
Dr Zhang Jinbin
Address 64344 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng
Singapore 308433
Country 64344 0
Singapore
Phone 64344 0
+6596542881
Fax 64344 0
Email 64344 0
jinbin_zhang@ttsh.com.sg

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
The baseline patient characteristics were similar in both groups. Overall success at insertion was higher for AG than LS, but the LS was easier to insert with a shorter time to insertion.

In terms of primary outcome, the AG has a better orophayngeal leak pressure (OLP) than LS. Peak inspiratory pressures rose following CO2 insufflation for laparoscopic surgery, but there is no significant difference in the intra-operative device performance and ventilatory parameters between the 2 devices.

There were no reported cases of regurgitation or aspiration with the use the devices. There were no significant differences in postoperative complications (sorethroat, dysphonia and dysphagia) between the two groups.

In summary, the LMA Supreme was easier to insert and has a shorter time to insertion. However, the AuraGain has a better seal pressure, or oropharyngeal leak pressure than the LMA Supreme and hence, may be a better device to use for laparoscopic surgery. There was no significant difference between the 2 devices in terms of intraoperative performance and post-operative complications