Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000653167
Ethics application status
Approved
Date submitted
22/03/2019
Date registered
1/05/2019
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Date results information initially provided
1/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Different airway devices affecting respiratory dynamics in kidney surgeries
Scientific title
Comparison of classic laringeal mask airway (LMA), proseal LMA and i-gel according to respiratory dynamics in retrograde intrarenal surgeries
Secondary ID [1] 297754 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
airway management 312093 0
kidney surgery 312094 0
Condition category
Condition code
Respiratory 310650 310650 0 0
Normal development and function of the respiratory system
Surgery 310714 310714 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The anesthesiologist administered the intervention. After induction and insertion of classic LMA/ProSeal LMA/ i-gel, volume controlled ventilation mode was set and we recorded the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. Surgery usually 60 minutes. We also recorded complications like sore throat, nausea and vomiting after surgery. Allocation is determined by computer randomized technique. The fidelity to the intervention is assessed by the audit of operation notes and anesthesia machine records.

The LMA is designed to sit in the patient’s hypopharynx and cover the supraglottic structures, thereby allowing relative isolation of the trachea.
LMA ProSeal has a built-in drain tube that allows expelled gastric content to bypass the pharynx. This specific feature is designed to decrease the risk of aspiration. The i-gel is the second generation supraglottic airway device, it works in harmony with the patient's anatomy so that compression and displacement trauma are significantly reduced

Intervention code [1] 313993 0
Treatment: Devices
Comparator / control treatment
classic LMA is the main comparator
Control group
Active

Outcomes
Primary outcome [1] 319498 0
ease of insertion
Timepoint [1] 319498 0
We tried to insert the airway device three times, if we insert it for the first time, we call it an easy insertion, if we insert it at the second or third time, we call it difficult
Primary outcome [2] 319909 0
time of airway devices insertion
Timepoint [2] 319909 0
We record the time of insertion from the time laryngeal mask airway passes the incisor teeth until we see end-tidal CO2.
Secondary outcome [1] 368486 0
complications like sore throat, nause and vomiting
There is no test or tools we simply asked patients about sore throat, and we observed them about nause and vomiting in the recovery room for half an hour
Timepoint [1] 368486 0
after surgery for half an hour

Eligibility
Key inclusion criteria
150 patients,
scheduled for retrograde intrarenal surgery
18-65 years
ASA 1-3
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with chronic obstructive pulmonary disease, with gastric regurgitation, and patients with pulmonary enfections

Study design
Purpose of the study
Diagnosis
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
2/03/2018
Date of last data collection
Anticipated
Actual
2/03/2018
Sample size
Target
150
Accrual to date
Final
149
Recruitment outside Australia
Country [1] 21352 0
Turkey
State/province [1] 21352 0
Ankara

Funding & Sponsors
Funding source category [1] 302278 0
Hospital
Name [1] 302278 0
Diskapi Yildirim Beyazit Education and Research hospital
Country [1] 302278 0
Turkey
Primary sponsor type
Hospital
Name
Diskapi Yildirim Beyazit Education and Research hospital
Address
Omer halis Demir caddesi no 12,
diskapi Ankara
postcode 06510
Country
Turkey
Secondary sponsor category [1] 302153 0
None
Name [1] 302153 0
Address [1] 302153 0
Country [1] 302153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302954 0
Diskapi Yildirim Beyazit Education and Research hospital
Ethics committee address [1] 302954 0
Omer Halis Demir caddesi no 12
diskapi Ankara
Ethics committee country [1] 302954 0
Turkey
Date submitted for ethics approval [1] 302954 0
Approval date [1] 302954 0
25/09/2017
Ethics approval number [1] 302954 0

Summary
Brief summary
The aim of this study is to compare the airway devices according to respiratory dynamics, ease and time of device insertion and effect on hemodynamic parameters and complications during renal operations
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91966 0
Dr gozde dalay
Address 91966 0
Diskapi Yildirim Beyazit Education and Research hospital
Omer Halis Demir caddesi no12 altindag
06510
Country 91966 0
Turkey
Phone 91966 0
+905335614727
Fax 91966 0
Email 91966 0
[email protected]
Contact person for public queries
Name 91967 0
Dr gozde dalay
Address 91967 0
Diskapi Yildirim Beyazit Education and Research hospital
Omer Halis Demir caddesi no12 altindag
06510
Country 91967 0
Turkey
Phone 91967 0
+905335614727
Fax 91967 0
Email 91967 0
[email protected]
Contact person for scientific queries
Name 91968 0
Dr gozde dalay
Address 91968 0
Diskapi Yildirim Beyazit Education and Research hospital
Omer Halis Demir caddesi no12 altindag
06510
Country 91968 0
Turkey
Phone 91968 0
+905335614727
Fax 91968 0
Email 91968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
ease and time of insertion of classic LMA, proseal LMA and i-gel
When will data be available (start and end dates)?
immediately after publication,no end date after publication
Available to whom?
to all
Available for what types of analyses?
ease and time of insertion with paired t- test
How or where can data be obtained?
unrestricted access via emaling principal investigator
[email protected]


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
No additional documents have been identified.