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Trial registered on ANZCTR


Registration number
ACTRN12615001089527
Ethics application status
Approved
Date submitted
3/08/2015
Date registered
16/10/2015
Date last updated
30/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the AuraGain laryngeal mask with the LMA Supreme - a cross-over study
Scientific title
A comparison of seal pressure and ease of use of the AuraGain laryngeal mask and the LMA Supreme mask in overweight and moderately obese female surgical patients - a crossover study
Secondary ID [1] 287208 0
2/15 ZP
Universal Trial Number (UTN)
U1111-1172-8657
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gynecological procedures
 295801 0
overweight 296138 0
surgery requiring use of a supraglottic airway device 296139 0
Condition category
Condition code
Anaesthesiology 296065 296065 0 0
Anaesthetics
Surgery 296406 296406 0 0
Other surgery
Diet and Nutrition 296407 296407 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Insertion of the AuraGain laryngeal mask
a) The AuraGain laryngeal mask is inserted through patient´s mouth and down to the perilaryngeal area (down airway) to keep the airway open during anaesthesia. The cuff at the end of the tube is then inflated to form a seal. The device is kept in place for the duration of surgery.
b) time of insertion and time of device removal - the device is inserted at start of general anaesthesia and removed on emergence post surgery.
c) the device is inserted by a doctor with a Board Certification in Anaesthesia - anaesthetist
d) approximate duration of the mask in place is five minutes for the first allocated mask, and for second mask the average time is approximately 1 hour, dependent on surgical procedure.
e) features differing from the control/comparator mask - broader breathing channel than LMA Supreme, gastric channel is not incorporated in the middle of the breathing tube (such as in the LMA Supreme) but in front of it.

2. Achievement of the cross-over design in the clinical setting.
With a patient already under general anaesthesia, patient will have the first allocated mask inserted, with number of attempts and time taken for insertion recorded. The seal pressure will then be recorded and 5 minutes after insertion, the mask will be removed. After a 1 minute washout period, the second mask will be inserted with attempts, timing and seal pressure recorded. This mask will stay in place for the duration of the surgical procedure until emergence from anaesthesia.
Intervention code [1] 292491 0
Treatment: Devices
Comparator / control treatment
Insertion of the Laryngeal Mask Airway Supreme
This mask is used as part of standard care during the procedures
Control group
Active

Outcomes
Primary outcome [1] 295739 0
Oropharyngeal seal pressure (cmH20)
This outcome will be measured with a sphygmomanometer (pressure monitor) located on the anaesthetic machine.
Pressure limit is set to 40 cmH2O, the APL valve is fully closed and fresh gas flow is set to 3 L/min. Oropharyngeal seal pressure is defined as the pressure inside the system when the first sounds are audible above the larynx using a sthetoscope.
Timepoint [1] 295739 0
1 min after successful insertion of a laryngeal mask
Reported by study administrator(s) (independent person present in the operating room during insertion) to a study logbook.
Secondary outcome [1] 316369 0
total success rate (%).
Reported by study administrator(s) (independent person present in the operating room during insertion of the device) to a study logbook.
Timepoint [1] 316369 0
5 minutes after successful insertion of a laryngeal mask
Secondary outcome [2] 316370 0
first attempt success rate (%)
Reported by study administrator(s) (independent person present in the operating room during insertion of the device) to a study logbook.
Timepoint [2] 316370 0
5 minutes after first insertion attempt of laryngeal mask airway.
Secondary outcome [3] 316371 0
total number of attempts (n)
Reported by study administrator(s) (independent person present in the operating room during insertion of the device) to a study logbook.
Timepoint [3] 316371 0
5 minutes after successful insertion of a laryngeal mask
Secondary outcome [4] 316372 0
time of insertion (sec)
timer started at start of first attempt and stopped once successful insertion confirmed by anaesthetist (first visible etCO2 tracking on the monitor).
Timepoint [4] 316372 0
Measured from start of the first attempt to confirmation of successful insertion.
Secondary outcome [5] 316373 0
Fibreoptic control (1-4)
Reported by the operator in the study log book on scale 1-4.
Timepoint [5] 316373 0
5 minutes after successful insertion of laryngeal mask airway.

Eligibility
Key inclusion criteria
elective surgery - gynaecology, general surgery, urology
ASA status 1-4
Body Mass Index 25-35 kg/m2
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
emergency surgery
increased risk for gastric content regurgitation and/or aspiration
Body Mass Index (BMI) over 35 kg/m2

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)
1. Patient will be given study information pack at least 24h prior to commencing the study
2. Randomization will be performed using the randomization freeware (www.graphpad.com). Generated numbers and codes will be placed into the sealed envelopes.
3. After signing the informed consent the patient will be taken to the operating room and the sealed enveloped with the order of interventions will be open.
4. Interventions will be performed in the randomized order - A = AuraGain inserted first, B= LMA Supreme inserted first.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. randomization freeware (www.graphad.com)
2. generation of 52 codes in total (A, B)
3. putting the codes into the sealed envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Sample size analysis
Based on the results of previous studies (Weber et al., Anaesthesia 2011; Theiler et al., Anesthesiology 2009) for differences in oropharyngeal seal pressure (OSP). Lowest significant difference - 3 cmH20 (10% of predicted value of OSP). Level of significance (alpha) = 0.05, beta error = 0.20.
46 minimum of patients, 51 (+10%) chosen for potential drop-outs or incomplete data. Freeware MGH Biostatistics Center (www.hedwig.mgh.harvard.edu/biostatistics) used.

2. Planned analysis of data
- testing for normal distribution (Shapiro-Wilk test of normality)
- analysis of data using parametric (chi-square, Fischer´s exact test) or non-parametric tests based on data distribution.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2015
Actual
20/10/2015
Date of last participant enrolment
Anticipated
29/02/2016
Actual
10/02/2016
Date of last data collection
Anticipated
1/03/2016
Actual
1/03/2016
Sample size
Target
51
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 7074 0
Czech Republic
State/province [1] 7074 0
Czech Republic, Prague

Funding & Sponsors
Funding source category [1] 291778 0
Hospital
Name [1] 291778 0
General University Hospital in Prague
Country [1] 291778 0
Czech Republic
Funding source category [2] 291779 0
University
Name [2] 291779 0
1st Medical Faculty, Charles University in Prague
Country [2] 291779 0
Czech Republic
Primary sponsor type
Hospital
Name
General University Hospital (Vseobecna fakultni nemocnice)
Address
U nemocnice 2, 128 08, Prague
Country
Czech Republic
Secondary sponsor category [1] 290444 0
None
Name [1] 290444 0
Address [1] 290444 0
Country [1] 290444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293296 0
Ethics Committee of the General University Hospital, Prague
Ethics committee address [1] 293296 0
Na bojisti 1
128 08, Prague/Praha 2
Ethics committee country [1] 293296 0
Czech Republic
Date submitted for ethics approval [1] 293296 0
10/04/2015
Approval date [1] 293296 0
25/06/2015
Ethics approval number [1] 293296 0
2/15 ZP

Summary
Brief summary
Comparison of insertion parameters and seal pressures between two types of supraglottic airway devices (breathing devices used for airway management) - an established device called Laryngeal Mask Airway Supreme and a novel device AuraGain Laryngeal Mask, using a cross-over design. Study participants will be females undergoing planned (elective) procedures (gynaecology, all types of general surgery, urology), with Body Mass Index between 25-35 kg/m2, without any additional risk for gastric content regurgitation/aspiration.
Study null hypothesis: no differences in the oropharyngeal seal pressures between the AuraGain LM and LMA Supreme.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 536 536 0 0
/AnzctrAttachments/369056-Ethical Approval 2 15 ZP.pdf

Contacts
Principal investigator
Name 59282 0
A/Prof Pavel Michalek
Address 59282 0
Dept of Anaesthesia and Intensive Medicine
General University Hospital
U nemocnice 2
128 02, Prague 2
Country 59282 0
Czech Republic
Phone 59282 0
+420 602776261
Fax 59282 0
+420 224962118
Email 59282 0
[email protected]
Contact person for public queries
Name 59283 0
Tomas Brozek
Address 59283 0
Dept of Anaesthesia and Intensive Medicine
General University Hospital
U nemocnice 2
128 02, Prague 2
Country 59283 0
Czech Republic
Phone 59283 0
+420 224962243
Fax 59283 0
Email 59283 0
[email protected]
Contact person for scientific queries
Name 59284 0
Pavel Michalek
Address 59284 0
Dept of Anaesthesia and Intensive Medicine
General University Hospital
U nemocnice 2
128 02, Prague 2
Country 59284 0
Czech Republic
Phone 59284 0
+420 602776261
Fax 59284 0
+420 224962118
Email 59284 0
[email protected]

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