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Trial registered on ANZCTR


Registration number
ACTRN12618001473257
Ethics application status
Approved
Date submitted
15/08/2018
Date registered
3/09/2018
Date last updated
3/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the clinical performance of airway devices in geriatric patients
Scientific title
Comparison of the clinical performance of i-gel, proseal LMA and Classic LMA in geriatric patients
Secondary ID [1] 295809 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
-Urologic conditions
 309243 0
-General surgery conditions 309244 0
Condition category
Condition code
Anaesthesiology 308119 308119 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All supraglottic airway devices (SGAD) were inserted by 5 years experienced anesthesist.
Group C: c-LMA inserted
Group P: Proseal LMA inserted
Group I: i-gel inserted
c-LMA with an inflatable cuff; is an airway device that provides an easier and more reliable airway than the facial mask, while protecting it from the disadvantages of endotracheal intubation.
p-LMA is an airway device developed by modifying c-LMA. The application of high-pressure positive ventilation is one of the advantages that the drain tube near the ventilation tube can be emptied stomach.
i-gel thermoplastic elastomer structure, it flexes at body temperature and fully conforms to the supraglottic texture, thus minimizing air leakage.It has the drain tube near the ventilation tube.
Insertion time, first-time insertion success rate, oropharyngeal leak and peak pressure, leak fraction and complications were recorded.
Intervention code [1] 312139 0
Treatment: Devices
Comparator / control treatment
The patients were randomized into three groups with the sealed envelope method.

- i-gel group inserted (C0mparator Group),

- proseal group inserted proseal (C0mparator Group),

-c-LMA group inserted c-LMA (Control Group)
Control group
Active

Outcomes
Primary outcome [1] 307095 0
oropharyngeal leak pressure:
After obtaining an effective and stable airway, leak pressure was assesed by closing the circuit (expiratory line) and allowing a fresh gas flow of 3 L/min to build airway pressure until audible leak was heard over the mouth (not permitted to exceed 40 cm H2O.
Timepoint [1] 307095 0
Aproximately 3 minute after obtaining an effective and stable airway
Secondary outcome [1] 350669 0
Airway device insertion time: The time taken from the removal of the face mask to appear on the capnogram on anesthesia machine monitor. It will be followed by an anesthetist using monitors timer.
Timepoint [1] 350669 0
The time (minute) the capnogram is seen on the anesthesia machine monitor.
Secondary outcome [2] 350670 0
Directly observed. Succesful placement was defined as a square wave tracing on the capnography with normal end tidal CO2 values.
Timepoint [2] 350670 0
The time (minute) the capnogram is seen on the anesthesia machine monitor.
Two trials will be allowed, and if they fail, they will be passed to the other SGADs. Two others will be allowed to try. If it fails again, the patient will be entubated.

Eligibility
Key inclusion criteria
ASA I-II who were scheduled to undergo hernioraphy or urologic surgery
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with respiratory
tract disease, known airway problems or any
condition that increases the risk of gastro-oesophageal
regurgitation were excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment outside Australia
Country [1] 20775 0
Turkey
State/province [1] 20775 0

Funding & Sponsors
Funding source category [1] 300404 0
Self funded/Unfunded
Name [1] 300404 0
Country [1] 300404 0
Primary sponsor type
Individual
Name
Reyhan Polat
Address
Health Science University
Diskapi Yildirim Beyazit Education and Research Hospital
Diskapi/Ankara-Turkey
06550
Country
Turkey
Secondary sponsor category [1] 299861 0
None
Name [1] 299861 0
Address [1] 299861 0
Country [1] 299861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301210 0
Diskapi Yildirim Beyazit Education and Research Hospital Ethics Comitee
Ethics committee address [1] 301210 0
Diskapi Yildirim Beyazit Education and Research Hospital

Diskapi/Ankara-Turkey
Ethics committee country [1] 301210 0
Turkey
Date submitted for ethics approval [1] 301210 0
Approval date [1] 301210 0
11/06/2018
Ethics approval number [1] 301210 0
51/20

Summary
Brief summary
Patients undergoing elective short duration surgery (<1-2 h) will be participated in this study. All devices will inserted into each patient in random order. Patients will be premedicated with 7.5 mg oral midazolam 15 min prior to surgery. Standard monitoring will be applied (ECG, BP, SpO2) and the anaesthesia will conducted according to local standards. Neuromuscular blocker will not administered. All supraglotic airway devices (c-LMA, proseal LMA and i-gel) will inserted in a standardised manner according to the manufacturers' instructions. Insertion time, first-time insertion success rate, oropharyngeal leak and peak pressure, leak fraction and complications will be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86234 0
A/Prof Reyhan Polat
Address 86234 0
Heltah Sciences University

Diskapi Yildirim Beyazit Education and Research Hospital

Diskapi/Ankara-Turkey

06550
Country 86234 0
Turkey
Phone 86234 0
+90 532 6734310
Fax 86234 0
Email 86234 0
[email protected]
Contact person for public queries
Name 86235 0
Reyhan Polat
Address 86235 0
Heltah Sciences University

Diskapi Yildirim Beyazit Education and Research Hospital

Diskapi/Ankara-Turkey

06550
Country 86235 0
Turkey
Phone 86235 0
+90 532 6734310
Fax 86235 0
Email 86235 0
[email protected]
Contact person for scientific queries
Name 86236 0
Reyhan Polat
Address 86236 0
Heltah Sciences University

Diskapi Yildirim Beyazit Education and Research Hospital

Diskapi/Ankara-Turkey

06550
Country 86236 0
Turkey
Phone 86236 0
+90 532 6734310
Fax 86236 0
Email 86236 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
EmbaseComparison of clinical performance of supraglottic airway devices in elderly patients: A prospective randomized trial.2021https://dx.doi.org/10.5222/jarss.2021.27147
N.B. These documents automatically identified may not have been verified by the study sponsor.