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Trial registered on ANZCTR


Registration number
ACTRN12616001464459
Ethics application status
Approved
Date submitted
12/10/2016
Date registered
20/10/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Success rate of upper gastrointestinal endoscope insertion directly into the oesophagus through a dedicated channel in the laryngeal mask airway (LMA) called the LMA GASTRO (Trademark)
Scientific title
Utility of a modified laryngeal mask airway (LMA) called the LMA GASTRO (Trademark) for upper gastrointestinal endoscopic procedures
Secondary ID [1] 289907 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LMA GASTRO (Trademark)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper gastrointestinal endoscopic procedures 299871 0
Condition category
Condition code
Anaesthesiology 299776 299776 0 0
Anaesthetics
Oral and Gastrointestinal 299777 299777 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After induction of anaesthesia with Propofol the LMA GASTRO (Trademark) is inserted into the upper airway with the patient’s head placed in the ‘sniffing’ position. The standardized method of insertion include lubricating the devise, before grasping it along the integral bite block and advancing into the mouth in the direction towards the hard palate whilst gliding downwards and backwards along the hard palate until definite resistance is felt. A maximum of three attempts by an anaesthetist is allowed before considered a failure of the laryngeal mask airway (LMA GASTRO Trademark). A breathing circuit is then connected to a dedicated channel for airway control
This is followed by the insertion of an upper-gastrointestinal endoscope, through a separate dedicated channel in the LMA GASTRO (Trademark), directly into the oesophagus by a gastroenterologist. A maximum of three attempts to insert the upper-gastrointestinal endoscope is allowed before considered a failure.
Intervention code [1] 295589 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299243 0
Endoscopic insertion success rate (binary outcome). The number of endoscopic attempts will be noted and considered a failure if the insertion was not successful in three attempts
Timepoint [1] 299243 0
This will be recorded after LMA GASTRO (Trademark) insertion with the insertion of the endoscope
Secondary outcome [1] 326614 0
Endoscopic first attempt success rate (binary outcome)
Timepoint [1] 326614 0
This will be recorded after LMA GASTRO (Trademark) insertion on insertion of the endoscope. Defined successful insertion of endoscope into the oesophagus on first attempt. A second attempt will be recorded if the endoscope is removed from the LMA GASTRO (Trademark) device
Secondary outcome [2] 326615 0
Ease of endoscope insertion (binary outcome) graded as easy or difficult by the attending gastroenterologist.
Timepoint [2] 326615 0
Graded as easy or difficult (binary outcome) on insertion of the endoscope. If the device could be inserted without any manipulation or requiring 1 manipulation, it is graded as 'easy’. If there was more than one manipulation required, it is graded as ‘difficult’
Secondary outcome [3] 326616 0
LMA GASTRO success rate (binary outcome). The number of LMA GASTRO (Trademark)attempts will be noted, and considered a failure if the insertion was not successful in three attempts
Timepoint [3] 326616 0
This will recorded after induction of anaesthesia at insertion of the LMA GASTRO (Trademark)
Secondary outcome [4] 326617 0
First attempt LMA GASTRO (Trademark) success rate defined as a successful insertion on first attempt (binary outcome). A second attempt will be recorded if the LMA GASTRO (Trademark) is removed from the upper airway and reinserted
Timepoint [4] 326617 0
This will recorded after induction of anaesthesia at insertion of the LMA GASTRO (Trademark)
Secondary outcome [5] 326618 0
Ease of LMA GASTRO (Trademark) insertion by the attending anaesthetist. Insertion graded as easy or difficult (binary outcome). This grading is based on manipulations required for insertion. The following maneuvers are included: (i) chin lift, (ii) jaw thrust, (iii) head extension and (iv) neck flexion
Timepoint [5] 326618 0
This will recorded after induction of anaesthesia at insertion of the LMA GASTRO (Trademark)
Secondary outcome [6] 326619 0
Lowest oxygen saturation intraoperatively (continuous outcome) measured using pulse oximetry
Timepoint [6] 326619 0
Recorded intraoperatively before patient transfer to postoperative recovery unit
Secondary outcome [7] 326620 0
Sore throat defined as painful (binary outcome)
Timepoint [7] 326620 0
Recorded after removal of the LMA GASTRO (Trademark) in the postoperative recovery unit
Secondary outcome [8] 328339 0
Blood on LMA GASTRO (Trademark) . Defined as the visualisation of macroscopic presence of blood on the device
Timepoint [8] 328339 0
Recorded after removal of the LMA GASTRO (Trademark) in the postoperative recovery unit
Secondary outcome [9] 328340 0
Airway compromise (binary outcome) defined as an airway event requiring airway intervention
Timepoint [9] 328340 0
Recorded after removal of the LMA GASTRO (Trademark) in the postoperative recovery unit
Secondary outcome [10] 328341 0
Postoperative laryngospasm defined as stridor which may progress to complete obstruction, increased respiratory effort, tracheal tug, paradoxical respiratory effort, oxygen desaturation with or without bradycardia, or airway obstruction which does not respond to a Guedel airway
Timepoint [10] 328341 0
Recorded after removal of the LMA GASTRO (Trademark) in the postoperative recovery unit
Secondary outcome [11] 328550 0
Absence of audible LMA GASTRO (Trademark) leak by applying positive pressure of 20cm H2O for a minimum of 3 seconds
Timepoint [11] 328550 0
This outcome will be recorded after the insertion of the LMA GASTRO (Trademark) and connection to breathing circuit
Secondary outcome [12] 328551 0
Fully inflated LMA GASTRO (Trademark) cuff volumes
Timepoint [12] 328551 0
Cuff volumes will be recorded directly after insertion of the LMA GASTRO (Trademark)
Secondary outcome [13] 328552 0
Total propofol dose (mg)
Timepoint [13] 328552 0
This will be the total intraoperative propofol dose measured from induction of anaesthesia until the end of the endoscopic procedure

Eligibility
Key inclusion criteria
ASA I –II, older than 18 years of age, fasted at least 6 hours for solids and 2 hours for clear liquids, undergoing elective upper gastro-intestinal endoscopic procedures requiring deep sedation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients at significant risk of pulmonary aspiration will be excluded based on anaesthetic clinical judgment after performing a clinical risk assessment. The clinical risk assessment will be performed based on patient history (focussing particularly on risk factors for aspiration) and physical examination to establish the risk of aspiration prior to enrolment. Possible risk factors for aspiration include:
1. Increased gastric content: delayed gastric emptying including lap band in situ, gastric hyper secretion, overfeeding, lack of fasting (less than six hours solids and two hours for clear fluid).
2. Increased tendency to regurgitate: symptomatic or uncontrolled gastro-oesophageal reflux, oesophageal strictures, Zenker Diverticulum, achalasia.
3. Laryngeal incompetence: Emergency surgery, head injuries, cerebral infarct, neuromuscular disorders (Parkinson’s disease, Gullian Barre), muscular dystrophies (cerebral palsy, cranial neuropathies)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed using SPSS version 21 and R-studio. Mean,standard deviation values will be estimated for continued outcomes while frequency and percentage will be computed for binary outcomes including sex, 95% Confidence intervals around the poiont estimate will be caculated where appropriate for the primary and secondary outcomes. Descriptive statistics will be used to present the results. P-value =0.05 are considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/06/2015
Date of last participant enrolment
Anticipated
31/12/2016
Actual
7/03/2017
Date of last data collection
Anticipated
31/12/2016
Actual
7/03/2017
Sample size
Target
292
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 6465 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 14018 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 294277 0
Hospital
Name [1] 294277 0
Royal Hobart Hospital Research Foundation
Country [1] 294277 0
Australia
Primary sponsor type
Hospital
Name
Royal Hobart Hospital
Address
48 Liverpool Street, Hobart, Tasmania, 7000
Country
Australia
Secondary sponsor category [1] 293112 0
None
Name [1] 293112 0
Address [1] 293112 0
Country [1] 293112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295708 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 295708 0
Ethics committee country [1] 295708 0
Australia
Date submitted for ethics approval [1] 295708 0
22/10/2014
Approval date [1] 295708 0
09/12/2014
Ethics approval number [1] 295708 0
H0014514

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

Contacts
Principal investigator
Name 68170 0
Dr Nico Terblanche
Address 68170 0
Department of Anaesthesia and Perioperative Medicine, Royal Hobart Hospital, 48 Liverpool Street, Hobart, TAS, 7000
Country 68170 0
Australia
Phone 68170 0
+61361667866
Fax 68170 0
Email 68170 0
[email protected]
Contact person for public queries
Name 68171 0
Robyn Seale
Address 68171 0
Department of Anaesthesia and Perioperative Medicine, Royal Hobart Hospital, 48 Liverpool Street, Hobart, TAS, 7000
Country 68171 0
Australia
Phone 68171 0
+613 6166 8977
Fax 68171 0
Email 68171 0
[email protected]
Contact person for scientific queries
Name 68172 0
Nico Terblanche
Address 68172 0
Department of Anaesthesia and Perioperative Medicine, Royal Hobart Hospital, 48 Liverpool Street, Hobart, TAS, 7000
Country 68172 0
Australia
Phone 68172 0
+61361667866
Fax 68172 0
Email 68172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
Dimensions AIEfficacy of a new dual channel laryngeal mask airway, the LMA®Gastro™ Airway, for upper gastrointestinal endoscopy: a prospective observational study2017https://doi.org/10.1016/j.bja.2017.11.075
N.B. These documents automatically identified may not have been verified by the study sponsor.