Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000108819
Ethics application status
Approved
Date submitted
4/10/2019
Date registered
3/02/2021
Date last updated
15/03/2022
Date data sharing statement initially provided
3/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
different ways of airway management in elective minor surgeries
Scientific title
different ways of laryngeal mask insertion in elective minor surgeries
Secondary ID [1] 299470 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
elective minor surgery 314696 0
Condition category
Condition code
Anaesthesiology 313045 313045 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The anesthesiologist will administer the intervention which will approximately last about 20-60 seconds. After induction and insertion of pro-Seal laryngeal mask either in a classic way, with a laryngoscope or with the help of video laryngoscope volume-controlled ventilation mode will be set. We will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. We will record the laryngeal mask insertion time and oropharyngeal leakage pressure. We will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. We will use the Briacombe scoring system to assess the position of laryngeal mask airway devices.
Intervention code [1] 315727 0
Treatment: Devices
Comparator / control treatment
Standard LMA insertion is performed without the help of a laryngoscope and video laryngoscope.
Control group
Active

Outcomes
Primary outcome [1] 321594 0
To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, with a laryngoscope or with the help of a video laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible ; 1, vocal cords not seen.
Timepoint [1] 321594 0
if we insert the laryngeal mask for the first time with no resistance, only with jaw opening movement, we call it an easy insertion. If slight resistance occurred while insertion, we call it Moderately difficult placement . if we insert it at second or third time, we exclude these patients.
Secondary outcome [1] 375504 0
Insertion time was defined from the time of removal of the facemask to the time of the appearance of first capnography upstroke. we assessed this outcome stopwatch,
Timepoint [1] 375504 0
we will record the time of insertion from the time laryngeal mask airway passes the incisor teeth until we see end-tidal CO2.
Secondary outcome [2] 375506 0
We will record: - complications like sore throat, hoarseness, nausea, and vomiting we simply asked patients about them
Timepoint [2] 375506 0
half an hour after surgery
Secondary outcome [3] 377644 0
Following electrocardiography, we will record the heartbeat.
Timepoint [3] 377644 0
every 5 minutes during surgery.
Secondary outcome [4] 377645 0
Bloodstain on the laryngeal mask. we will search the LMA for it
Timepoint [4] 377645 0
post-extubation
Secondary outcome [5] 377646 0
extremity and head movement during laryngeal mask placement we observed the patient
Timepoint [5] 377646 0
Checking extremity, and head movement when the laryngeal mask is installed
Secondary outcome [6] 377647 0
The development and severity of coughing, laryngospasm we observed the patient
Timepoint [6] 377647 0
post-extubation
Secondary outcome [7] 377931 0
We will record the respiratory dynamics (tidal volume, peak airway pressure, end-tidal CO2) from the mechanical ventilator,
Timepoint [7] 377931 0
every 5 minutes during surgery. we will record the mechanical ventilation machine.
Secondary outcome [8] 381910 0
We will record the mean arterial pressures. By monitoring non-invasive blood pressure.
Timepoint [8] 381910 0
Every 5 minutes during surgery.
Secondary outcome [9] 381911 0
We will record the oxygen saturation. With pulse oximeter evaluation.
Timepoint [9] 381911 0
every 5 minutes during surgery.

Eligibility
Key inclusion criteria
120 patients
elective minor urological surgery
18-65 years
ASA Physical Status Classification System 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, previous jaw surgery, body mass index more than 40 and patients with pulmonary infections

Study design
Purpose of the study
Educational / counselling / training
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
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 21905 0
Turkey
State/province [1] 21905 0

Funding & Sponsors
Funding source category [1] 303970 0
Hospital
Name [1] 303970 0
Diskapi Yildirim Beyazit Education and Research Hospital
Country [1] 303970 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] 304141 0
None
Name [1] 304141 0
Address [1] 304141 0
Country [1] 304141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304470 0
Diskapi yildirim beyazit education and research hospital
Ethics committee address [1] 304470 0
Ethics committee country [1] 304470 0
Turkey
Date submitted for ethics approval [1] 304470 0
Approval date [1] 304470 0
10/07/2019
Ethics approval number [1] 304470 0

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

Contacts
Principal investigator
Name 97058 0
Dr filiz akaslan
Address 97058 0
Diskapi Yildirim Beyazit Education and Research Hospital Omer Halis Demir caddesi no 12 altindag 06510
Country 97058 0
Turkey
Phone 97058 0
+905056432470
Fax 97058 0
Email 97058 0
[email protected]
Contact person for public queries
Name 97059 0
filiz akaslan
Address 97059 0
Diskapi Yildirim Beyazit Education and Research Hospital Omer Halis Demir caddesi no 12 altindag 06510
Country 97059 0
Turkey
Phone 97059 0
+905056432470
Fax 97059 0
Email 97059 0
[email protected]
Contact person for scientific queries
Name 97060 0
filiz akaslan
Address 97060 0
Diskapi Yildirim Beyazit Education and Research Hospital Omer Halis Demir caddesi no 12 altindag 06510
Country 97060 0
Turkey
Phone 97060 0
+905056432470
Fax 97060 0
Email 97060 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• to all

Conditions for requesting access:
• -

What individual participant data might be shared?
• ease and time of insertion the proseal laryngeal mask with classical technique, laryngoscope and video laryngoscope-assisted technique

What types of analyses could be done with individual participant data?
• Chi-square test to evaluate the ease of proseal laryngeal placement with the consent of the participants. A T-test can be used to evaluate the laryngeal mask insertion time.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately after publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• [email protected], access via web address, this studie can be access data available after work published.

Are there extra considerations when requesting access to individual participant data?
No


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.